Director, Site Quality - Memphis - Integra LifeSciences
Cordova, TN
About the Job
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
SUMMARY
The on-site Quality Director is responsible for the efficient and compliant management of the development, implementation and maintenance of the quality assurance systems and activities at the BioDLogics/Integra LifeSciences - Memphis. The Director of Site Quality is responsible for leading the Quality Assurance, Quality Control, Quality Systems, Quality Engineering, Quality Compliance, Training and Donor Services departments in support of the Memphis, TN human tissue manufacturing facility. This role will lead a team in a highly specialized, rapidly growing human tissue processing facility where raw material is acquired from participating hospitals and third-party donor recovery partners. The Director will drive operational efficiencies and champion Quality initiatives; as well as partner with Site Operations, interact routinely with suppliers, vendors, corporate quality, corporate operations and regulatory affairs. The Director will provide leadership and direction ensuring that the entire product lifecycle and chain of custody are compliant, well-controlled, efficient and within company standards and customer requirements as well as State and Federal Regulations.
SUPERVISION RECEIVED
Under direct supervision of VP, Quality Operations TT
SUPERVISION EXERCISED
Quality Assurance, Quality Control, Quality System, Quality Engineering, Quality Compliance, Training and Donor Services.
ESSENTIAL DUTIES AND RESPONSIBILITIES
+ Strategically and tactically lead the activities and performance to ensure focused compliance within a multiple shift specialized manufacturing/process setting.
+ Establish, implement, and direct policies, procedures and processes as necessary to ensure full compliance with the BioDLogics/Integra LifeSciences QMS.
+ Direct all activities, functions, and personnel in the following areas:
+ Quality Engineering
+ Quality Assurance
+ Quality Control
+ Quality Compliance
+ Complaints/MDRs investigation and approval
+ CAPA/NCMR/MRB/Deviations
+ Document and Change Control
+ Training
+ Internal and External Auditing
+ Product Release and Batch Record reviews
+ Quality record reviews, inspections and maintenance
+ Data Trending and Analytics
+ Quality Management Review preparation for the site.
+ Ensure ongoing site compliance to documented processes, current Good Manufacturing Procedures (GMP), Current Good Documentation Procedures (cGDP) and applicable regulations / standard.
+ Ensure all documentation regarding the Quality Management System is effectively maintained.
+ Ensure the site is functioning in a high state of readiness and compliance and meets established criteria for testing and product release schedules.
+ Management of Training Program and Records Management.
+ Ensures trend analysis of QA key indicators and other quality metrics.
+ Support internal and external audits in the capacity of front room lead and provide backroom leadership for all Integra, FDA, ISO, AATB and other regulatory and certification organizations.
+ Direct all activities associated with product or facility non-compliance conditions.
+ Ensure control of customer owned products including but not limited to; components, finished goods, intellectual property including ensuring HIPPA information is protected.
+ Manages Site Quality Budget to achieve organizational goals.
+ Support a culture of quality and promote teamwork.
+ Support projects, goals, and continuous improvement initiatives, as determined by the Integra organization or executive/senior quality management.
+ Ensure accuracy of data reporting for the site and communicate regularly in management reviews.
+ Foster an environment of strong customer service, open communication and partnership.
+ Operates effectively with minimal supervision.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Education & Experience:
+ Required Bachelor's degree in Science, Engineering or related discipline with 10+ years of experience leading a team (direct reports). Or Master's degree in Science, Engineering or related discipline with 8+ years of experience leading a team (direct reports). Or Doctoral degree in Science, Engineering or related discipline with 5+ years of experience leading a team (direct reports).
+ Experience leading a site quality organization.
+ Quality management experience in a manufacturing environment.
+ Transformative leader with focus on continuous improvement.
+ Strong Root Cause Analysis and problem-solving skills.
+ Experience with External Regulatory Agency audits (i.e., Notified Bodies and FDA).
+ Experience as front room lead during external audits.
+ Experience with Training program development / implementation.
+ Certified Tissue Bank Specialist (CTBS), Six Sigma, CQA, and/or CQE preferred.
+ Knowledge of Trackwise is preferred.
+ Expert knowledge in quality system and regulatory documentation writing and editing skills (i.e., CAPA, NC).
+ Excellent leadership skills with a team-focused attitude.
+ Demonstrated knowledge and understanding of applicable national and international regulations and standards.
+ Demonstrated organizational and analytical skills.
+ Strong communication skills, both written and verbal.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
SUMMARY
The on-site Quality Director is responsible for the efficient and compliant management of the development, implementation and maintenance of the quality assurance systems and activities at the BioDLogics/Integra LifeSciences - Memphis. The Director of Site Quality is responsible for leading the Quality Assurance, Quality Control, Quality Systems, Quality Engineering, Quality Compliance, Training and Donor Services departments in support of the Memphis, TN human tissue manufacturing facility. This role will lead a team in a highly specialized, rapidly growing human tissue processing facility where raw material is acquired from participating hospitals and third-party donor recovery partners. The Director will drive operational efficiencies and champion Quality initiatives; as well as partner with Site Operations, interact routinely with suppliers, vendors, corporate quality, corporate operations and regulatory affairs. The Director will provide leadership and direction ensuring that the entire product lifecycle and chain of custody are compliant, well-controlled, efficient and within company standards and customer requirements as well as State and Federal Regulations.
SUPERVISION RECEIVED
Under direct supervision of VP, Quality Operations TT
SUPERVISION EXERCISED
Quality Assurance, Quality Control, Quality System, Quality Engineering, Quality Compliance, Training and Donor Services.
ESSENTIAL DUTIES AND RESPONSIBILITIES
+ Strategically and tactically lead the activities and performance to ensure focused compliance within a multiple shift specialized manufacturing/process setting.
+ Establish, implement, and direct policies, procedures and processes as necessary to ensure full compliance with the BioDLogics/Integra LifeSciences QMS.
+ Direct all activities, functions, and personnel in the following areas:
+ Quality Engineering
+ Quality Assurance
+ Quality Control
+ Quality Compliance
+ Complaints/MDRs investigation and approval
+ CAPA/NCMR/MRB/Deviations
+ Document and Change Control
+ Training
+ Internal and External Auditing
+ Product Release and Batch Record reviews
+ Quality record reviews, inspections and maintenance
+ Data Trending and Analytics
+ Quality Management Review preparation for the site.
+ Ensure ongoing site compliance to documented processes, current Good Manufacturing Procedures (GMP), Current Good Documentation Procedures (cGDP) and applicable regulations / standard.
+ Ensure all documentation regarding the Quality Management System is effectively maintained.
+ Ensure the site is functioning in a high state of readiness and compliance and meets established criteria for testing and product release schedules.
+ Management of Training Program and Records Management.
+ Ensures trend analysis of QA key indicators and other quality metrics.
+ Support internal and external audits in the capacity of front room lead and provide backroom leadership for all Integra, FDA, ISO, AATB and other regulatory and certification organizations.
+ Direct all activities associated with product or facility non-compliance conditions.
+ Ensure control of customer owned products including but not limited to; components, finished goods, intellectual property including ensuring HIPPA information is protected.
+ Manages Site Quality Budget to achieve organizational goals.
+ Support a culture of quality and promote teamwork.
+ Support projects, goals, and continuous improvement initiatives, as determined by the Integra organization or executive/senior quality management.
+ Ensure accuracy of data reporting for the site and communicate regularly in management reviews.
+ Foster an environment of strong customer service, open communication and partnership.
+ Operates effectively with minimal supervision.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Education & Experience:
+ Required Bachelor's degree in Science, Engineering or related discipline with 10+ years of experience leading a team (direct reports). Or Master's degree in Science, Engineering or related discipline with 8+ years of experience leading a team (direct reports). Or Doctoral degree in Science, Engineering or related discipline with 5+ years of experience leading a team (direct reports).
+ Experience leading a site quality organization.
+ Quality management experience in a manufacturing environment.
+ Transformative leader with focus on continuous improvement.
+ Strong Root Cause Analysis and problem-solving skills.
+ Experience with External Regulatory Agency audits (i.e., Notified Bodies and FDA).
+ Experience as front room lead during external audits.
+ Experience with Training program development / implementation.
+ Certified Tissue Bank Specialist (CTBS), Six Sigma, CQA, and/or CQE preferred.
+ Knowledge of Trackwise is preferred.
+ Expert knowledge in quality system and regulatory documentation writing and editing skills (i.e., CAPA, NC).
+ Excellent leadership skills with a team-focused attitude.
+ Demonstrated knowledge and understanding of applicable national and international regulations and standards.
+ Demonstrated organizational and analytical skills.
+ Strong communication skills, both written and verbal.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Source : Integra LifeSciences