Associate Director/Sr Manager, QC Microbiology, Fremont CA - Boehringer Ingelheim
Fremont, CA
About the Job
Description
Responsible for ensuring that the Quality Control Microbiology Department provides appropriate oversight over biopharma clinical and commercial GMP operations to ensure that products are tested to comply with the requirements of regulatory filings and do not place patients at risk due to inadequate safety, quality or efficacy.As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.
Duties & Responsibilities
+ Responsible for all Quality Control Micro Lab activities at an operational site both clinical and commercial.
+ Ensures that testing requirements are effectively established and maintained for area of oversight.
+ Ensures that all testing requirements meet regulatory expectations and requirements.
+ Responsible for the Environmental Monitoring program and Microbiological in-process/biosafety monitoring program at the site
+ Ensures that OOS and deviations from established procedures are documented per procedures.
+ Ensures that all changes that potentially impact product quality are documented per procedure.
+ Advises site management regarding Quality Control Micro Lab strategies.
+ Provide directions for senior staff based on global and site strategies.
+ Provide input to any global compliance SOPs; represent the site at any global compliance meetings related to Micro.
+ Coach, mentor, lead and manage departmental employees. Ensure that training and other personal development programs are in place for succession planning and the development of subordinates.
+ Ensure that performance opportunities are pro-actively managed through the Performance Management system and that staff are properly trained.
+ Prepare capital, expense, and head count budgets.
+ Provide technical expertise on microbial contamination investigations at the site; lead investigations.
+ Provide training on Contamination Awareness to the site.
+ Acts as the Subject Matter Expert for the site during regulatory inspections.
Sr Manager Requirements
Requires a minimum of a Bachelor's Degree in Chemistry, Biology, Biochemistry or closely related discipline.
• Requires a minimum of eight (8) years in a laboratory environment including at least six (6) years’ experience with analytical equipment and four (4) years’ experience with cGXP or other regulations (DEA, EPA, DEQ) required.
• Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of six (6) years in a management position preferred.
• One (1) to three (3) years project management experience
• Knowledge of SAP and LIMS desired.
• Ability to develop and manage budget plans and forecasts.
• Physical Demands / Surroundings: Indoor/Office environment. May require period of standing for extended time period.
• Visual Demands: Able to read and see clearly.
• Temperaments/Mental Requirements: Attention to detail/analytical/integrity/initiative/independence/persistence/stress tolerance/self control/self-directed/leadership
• Attendance / Schedule: Flexible schedule to accommodate workload. May require off-shift work hours as job demands.
Associate Director Requirements
+ Bachelors´ degree with a focus in Microbiology, Biology or Biopharmaceuticals required.
+ More than six (6) years´ experience leading employees and projects.
+ At least seven (7) to ten (10) years´ experience demonstrating excellent communications, facilitation, presentation and technical writing skills
+ Advanced skills in solving complex problems and ability to bring issues to resolution.
+ Advanced skills in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities
+ Demonstrate advanced ability to evaluate and apply compliance requirements/guidelines to complex situations
+ Demonstrate advanced leadership skills with focus on strategy and continuous improvement skills
+ Knowledge of regulations and practices pertaining to pharmaceutical/biological products in area of responsibility
+ Ability to interact with regulatory agencies
+ Advanced skills leading motivating, influencing, and negotiating staff.
+ Highly regulated (FDA, DEA, EMEA, and EPA). Significant technical/operational risk due to increasing legal and regulatory complexity.
+ The combination of intense regulation (i.e. pharmaceutical production, controlled substances, environmental and safety, etc.), overall risk of operations, and a dynamic process driven production environment results; in a complex business/operational model with multiple competing factors needing to be balanced.
+ Coordination and communication between multiple departments, including manufacturing, process science and maintenance.
+ Oversight of quality documents requires a high level of technical and regulatory knowledge and organization
+ Work is primarily directed at the site; however, interaction with colleagues at other USA and worldwide sites is frequent
+ Decisions directly affect the supply of clinical and commercial products and therefore have an impact to the overall success of the organization
+ Effectiveness of quality function assures no interruption of product supply due to regulatory non-conformance.
Desired Experience, Skills and Abilities:
+ Eleven (11) to fifteen (15) years´ experience in Quality.
+ Six (6) to nine (9) years management experience, including experience managing a large group.
Compensation Data
This position offers a base salary typically between (132,000) and (226,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. (https://www.boehringer-ingelheim.us/sites/us/files/files/2021-bi-benefits-overview.pdf)
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Responsible for ensuring that the Quality Control Microbiology Department provides appropriate oversight over biopharma clinical and commercial GMP operations to ensure that products are tested to comply with the requirements of regulatory filings and do not place patients at risk due to inadequate safety, quality or efficacy.As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.
Duties & Responsibilities
+ Responsible for all Quality Control Micro Lab activities at an operational site both clinical and commercial.
+ Ensures that testing requirements are effectively established and maintained for area of oversight.
+ Ensures that all testing requirements meet regulatory expectations and requirements.
+ Responsible for the Environmental Monitoring program and Microbiological in-process/biosafety monitoring program at the site
+ Ensures that OOS and deviations from established procedures are documented per procedures.
+ Ensures that all changes that potentially impact product quality are documented per procedure.
+ Advises site management regarding Quality Control Micro Lab strategies.
+ Provide directions for senior staff based on global and site strategies.
+ Provide input to any global compliance SOPs; represent the site at any global compliance meetings related to Micro.
+ Coach, mentor, lead and manage departmental employees. Ensure that training and other personal development programs are in place for succession planning and the development of subordinates.
+ Ensure that performance opportunities are pro-actively managed through the Performance Management system and that staff are properly trained.
+ Prepare capital, expense, and head count budgets.
+ Provide technical expertise on microbial contamination investigations at the site; lead investigations.
+ Provide training on Contamination Awareness to the site.
+ Acts as the Subject Matter Expert for the site during regulatory inspections.
Sr Manager Requirements
Requires a minimum of a Bachelor's Degree in Chemistry, Biology, Biochemistry or closely related discipline.
• Requires a minimum of eight (8) years in a laboratory environment including at least six (6) years’ experience with analytical equipment and four (4) years’ experience with cGXP or other regulations (DEA, EPA, DEQ) required.
• Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of six (6) years in a management position preferred.
• One (1) to three (3) years project management experience
• Knowledge of SAP and LIMS desired.
• Ability to develop and manage budget plans and forecasts.
• Physical Demands / Surroundings: Indoor/Office environment. May require period of standing for extended time period.
• Visual Demands: Able to read and see clearly.
• Temperaments/Mental Requirements: Attention to detail/analytical/integrity/initiative/independence/persistence/stress tolerance/self control/self-directed/leadership
• Attendance / Schedule: Flexible schedule to accommodate workload. May require off-shift work hours as job demands.
Associate Director Requirements
+ Bachelors´ degree with a focus in Microbiology, Biology or Biopharmaceuticals required.
+ More than six (6) years´ experience leading employees and projects.
+ At least seven (7) to ten (10) years´ experience demonstrating excellent communications, facilitation, presentation and technical writing skills
+ Advanced skills in solving complex problems and ability to bring issues to resolution.
+ Advanced skills in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities
+ Demonstrate advanced ability to evaluate and apply compliance requirements/guidelines to complex situations
+ Demonstrate advanced leadership skills with focus on strategy and continuous improvement skills
+ Knowledge of regulations and practices pertaining to pharmaceutical/biological products in area of responsibility
+ Ability to interact with regulatory agencies
+ Advanced skills leading motivating, influencing, and negotiating staff.
+ Highly regulated (FDA, DEA, EMEA, and EPA). Significant technical/operational risk due to increasing legal and regulatory complexity.
+ The combination of intense regulation (i.e. pharmaceutical production, controlled substances, environmental and safety, etc.), overall risk of operations, and a dynamic process driven production environment results; in a complex business/operational model with multiple competing factors needing to be balanced.
+ Coordination and communication between multiple departments, including manufacturing, process science and maintenance.
+ Oversight of quality documents requires a high level of technical and regulatory knowledge and organization
+ Work is primarily directed at the site; however, interaction with colleagues at other USA and worldwide sites is frequent
+ Decisions directly affect the supply of clinical and commercial products and therefore have an impact to the overall success of the organization
+ Effectiveness of quality function assures no interruption of product supply due to regulatory non-conformance.
Desired Experience, Skills and Abilities:
+ Eleven (11) to fifteen (15) years´ experience in Quality.
+ Six (6) to nine (9) years management experience, including experience managing a large group.
Compensation Data
This position offers a base salary typically between (132,000) and (226,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. (https://www.boehringer-ingelheim.us/sites/us/files/files/2021-bi-benefits-overview.pdf)
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Source : Boehringer Ingelheim
