Senior Manager, Clinical Quality Assurance - United Therapeutics
Silver Spring, MD
About the Job
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
This role is responsible for the management and execution of clinical quality oversight activities in support of the organization's active clinical trials, and to maintain compliance to federal and international GCP regulations, as well as, internal policies and procedures. This role shall interact closely with clinical project team members to provide compliance support in making key trial-related decisions. This is a hybrid position with 3 days/week onsite at our Silver Spring, MD office and 2 days/week work from home.
+ Develop Clinical Quality Assurance (CQA) Standard Operating Procedures and policies and coordinate the company SOP development and maintenance process to ensure compliance with federal and international regulations
+ Ensure continuous improvement and management of the organization's audit program, to ensure vendors utilized for the execution and management of clinical trials are compliant and approved for the services provided. This process also includes internal system and documentation audits as well as external audits of clinical sites, CROs, bioanalytical laboratories, etc.
+ Manage regulatory agency and other audits/inspections of Unither Bioengineering and prepare investigator sites for FDA or other regulatory agency inspections
+ Actively collaborate with other functional areas and investigator sites to prepare viable audit responses and evaluate the adequacy of corrective actions
+ Consult, review and approve study-specific training curriculums to ensure training compliance for the management and conduct of clinical studies
+ Serve as in-house consultant for understanding project-specific requirements regarding federal and international regulations (e.g., privacy, data protection, ethics) to facilitate GCP compliance throughout the lifecycle of a trial
+ Conduct pre- and post-study document reviews and take corrective action
+ Monitor compliance with all regulatory requirements for the protection of human subjects
+ Establish and maintain clinical quality database of observations for quality analysis and assessment and identifies compliance risks
+ Train and mentor junior CQA staff
+ Often interact with the QMS Specialists to support the review and approval of training curriculums, documents, deviation investigations, CAPAs, and effectiveness checks
+ Provide the QA department QMS data to generate departmental metrics for trending and routine Quality Management Reviews
+ Serve as the clinical quality advisor for all studies managed and/or conducted by Uniter Bioengineering
+ Develop and review Quality Technical Agreements with critical vendors
+ Generate study-specific Clinical Quality Oversight Plans and execute accordingly
+ Perform all other duties as assigned
For this role you will need
Minimum Requirements
+ Bachelor’s Degree in a scientific or related discipline and
+ 10+ years of direct biotech/pharmaceutical industry experience
+ 5+ years of experience within GCP Quality
+ GCP experience
+ Experience performing CQA functions in/or at both CRO as well as Sponsor companies
+ Experience with process and documentation audits; experience developing process documentation; ability to understand and interpret national, regional, and local regulations
+ MS Office suite of programs, advanced knowledge of MS Word and Excel
+ Strong interpersonal and written/oral communication skills to facilitate interaction with internal and external customers
+ The ability to work effectively and diplomatically with supervisors, peers and support personnel both internal and external to the organization.
+ Very strong time management and organizational skills
+ Ability to perform and multi-task in a fast paced and demanding environment
+ Attention to detail and accuracy in work
+ Adaptability to successfully respond to changing priorities and circumstances
+ Ability to work independently with occasional oversight
+ Strong ability to identify gaps and implement creative ideas for continuous improvement
+ Experience with electronic quality management systems such as Trackwise
+ Experience with electronic publishing tools and electronic document management systems
+ Travel up to 25% to conduct site and vendor compliance audits and attend meetings
Preferred Qualifications
+ 2+ years in a clinical process or operations role
+ Certified Quality Manager (CQM)-ASQ RQAP-GCP and/or ASQ-CQA
+ Experience providing support with trials crossing into International regulation requirements for the purposes of GCP compliance and EMA expectations
+ Good Laboratory Practice (GLP) experience
The salary for this position ranges from $135,000 to $170,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities .
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients._
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
This role is responsible for the management and execution of clinical quality oversight activities in support of the organization's active clinical trials, and to maintain compliance to federal and international GCP regulations, as well as, internal policies and procedures. This role shall interact closely with clinical project team members to provide compliance support in making key trial-related decisions. This is a hybrid position with 3 days/week onsite at our Silver Spring, MD office and 2 days/week work from home.
+ Develop Clinical Quality Assurance (CQA) Standard Operating Procedures and policies and coordinate the company SOP development and maintenance process to ensure compliance with federal and international regulations
+ Ensure continuous improvement and management of the organization's audit program, to ensure vendors utilized for the execution and management of clinical trials are compliant and approved for the services provided. This process also includes internal system and documentation audits as well as external audits of clinical sites, CROs, bioanalytical laboratories, etc.
+ Manage regulatory agency and other audits/inspections of Unither Bioengineering and prepare investigator sites for FDA or other regulatory agency inspections
+ Actively collaborate with other functional areas and investigator sites to prepare viable audit responses and evaluate the adequacy of corrective actions
+ Consult, review and approve study-specific training curriculums to ensure training compliance for the management and conduct of clinical studies
+ Serve as in-house consultant for understanding project-specific requirements regarding federal and international regulations (e.g., privacy, data protection, ethics) to facilitate GCP compliance throughout the lifecycle of a trial
+ Conduct pre- and post-study document reviews and take corrective action
+ Monitor compliance with all regulatory requirements for the protection of human subjects
+ Establish and maintain clinical quality database of observations for quality analysis and assessment and identifies compliance risks
+ Train and mentor junior CQA staff
+ Often interact with the QMS Specialists to support the review and approval of training curriculums, documents, deviation investigations, CAPAs, and effectiveness checks
+ Provide the QA department QMS data to generate departmental metrics for trending and routine Quality Management Reviews
+ Serve as the clinical quality advisor for all studies managed and/or conducted by Uniter Bioengineering
+ Develop and review Quality Technical Agreements with critical vendors
+ Generate study-specific Clinical Quality Oversight Plans and execute accordingly
+ Perform all other duties as assigned
For this role you will need
Minimum Requirements
+ Bachelor’s Degree in a scientific or related discipline and
+ 10+ years of direct biotech/pharmaceutical industry experience
+ 5+ years of experience within GCP Quality
+ GCP experience
+ Experience performing CQA functions in/or at both CRO as well as Sponsor companies
+ Experience with process and documentation audits; experience developing process documentation; ability to understand and interpret national, regional, and local regulations
+ MS Office suite of programs, advanced knowledge of MS Word and Excel
+ Strong interpersonal and written/oral communication skills to facilitate interaction with internal and external customers
+ The ability to work effectively and diplomatically with supervisors, peers and support personnel both internal and external to the organization.
+ Very strong time management and organizational skills
+ Ability to perform and multi-task in a fast paced and demanding environment
+ Attention to detail and accuracy in work
+ Adaptability to successfully respond to changing priorities and circumstances
+ Ability to work independently with occasional oversight
+ Strong ability to identify gaps and implement creative ideas for continuous improvement
+ Experience with electronic quality management systems such as Trackwise
+ Experience with electronic publishing tools and electronic document management systems
+ Travel up to 25% to conduct site and vendor compliance audits and attend meetings
Preferred Qualifications
+ 2+ years in a clinical process or operations role
+ Certified Quality Manager (CQM)-ASQ RQAP-GCP and/or ASQ-CQA
+ Experience providing support with trials crossing into International regulation requirements for the purposes of GCP compliance and EMA expectations
+ Good Laboratory Practice (GLP) experience
The salary for this position ranges from $135,000 to $170,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities .
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients._
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
Source : United Therapeutics
