Senior Manager, Quality Assurance

Boehringer Ingelheim Fremont, CA

About the Job

Description:

Description\:

 

 

This position is responsible for ensuring compliance of Fremont site manufacturing processes according to cGMP regulations.  Also responsible for implementing, maintaining, and monitoring all Quality processes necessary for that assurance. This includes leading skilled people, running the operations according to cGMP regulations, and identifying and implementing business process improvements and that will drive Fremont’s business performance and Quality innovation.

 

Incumbent provides technical expertise on Quality Assurance standards and processes to team members; and provides input on QA strategy to the Director, Quality Assurance who has oversight on the interactions of strategy within all Quality groups.

 

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\:

 

  • Plans, directs and manages the work of the BI Fremont Quality Assurance group; establishes department mission statements; and provides technical leadership to ensure all necessary quality checks are completed on time, and according to SOPs.

  • Identifies deviations from SOPs in manufacturing operations; records and reports issues to appropriate parties; recommends corrective action and follows up to ensure resolved.

  • Provides oversight for the development of project budgets and monitors expenditures.

  • Optimizes allocated department resources.

  • Prepares for, manages and coordinates internal and customer audits including\:

    • Coordination with internal contacts/customers on audit agenda

    • Completion of any internal/customer pre-audit requirements (questionnaires, etc.)

    • Coordination with internal departments on audit schedule

    • Coordination with internal departments and/or customer on responses to any observations

    • Overseeing tracking of CAPAs related to audits to monitor for timely completion.

  • Prepares for, manages and coordinates regulatory audits including\:

    • Leading inspection readiness efforts as a part of cross-functional, multi-departmental team

    • Coordination with internal departments on regulatory audit schedule as available

    • Coordination with internal departments and regulatory agencies on responses to any observations

    • Overseeing tracking of CAPAs related to regulatory audits to monitor for timely completion

  • Reviews and approves of site Standard Operating Procedures to ensure compliance with cGMP requirements.

  • Proposes and executes process and procedural changes to improve QA process performance, robustness, and efficiency.

  • Collaborates functionally and cross-functionally to meet organization objectives and initiatives.

  • May participate in BI interactions with various governmental agencies/regulators and external auditors

  • Serves as an active member of the Quality Management Team

  • Serves as a One BioPharma expert to identify best practices across the organization, shares and implements as appropriate

  • Interacts with site efforts to ensure consistency in policies and practices

  • Establishes department-wide business practices

 

 

Requirements\:

 

  • Requires a Bachelor's, Master's or PhD degree, from an accredited institution, preferably in Life Sciences Engineering or similar pursuit.

  • Requires a minimum of seven (7) years of experience working in the Quality aspects of a life sciences or closely related industry.

  • Requires a minimum of three (3) years of management and/or leadership experience, including experience managing within complex matrix organizations and projects.

  • Must have demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.

  • Negotiating skills

  • Overall understanding of Quality Assurance specifications and process

  • Budgeting

  • Goal setting

  • In-depth understanding of Manufacturing/Pharma Business

  • Strong team leadership skills

  • Strong staff coaching and development skills

  • Strong ability to communicate in an open, customer-focused manner

  • Strong ability to influence in a team environment and collaborate with peers.

  • Strong understanding and appreciation for regulatory requirements and quality and compliance standards under which the Fremont site is operating

  • Strong team leadership skills

  • Strong ability to set vision and direction, set expectations and motivate

  • Strategic thinking and planning.

  • Performance focused, persistent, sound decision-making, open minded, innovative/creative and results oriented.

  • Ability to interpret and relate Quality standards for implementation and review to functional areas.

  • In-depth knowledge of relevant Standard Operating Procedures, Good Manufacturing Practices, Food and Drug Administration, and other national and international regulatory requirements related to quality testing.

  • Ability to work effectively on problems of diverse scope, with analysis/evaluation of data.

  • Ability to effectively communicate both verbally and in writing to peers, management and other functions; superior interpersonal effectiveness, facilitation and organizational skills.

  • High level of personal motivation and initiative, and ability to work independently on projects.

  • Ability to adapt and be flexible with project changes as well as a continuously-improving work environment.

  • Ability and willingness to maintain accurate and factual hard-copy and electronic records.

  • Ability and willingness to work, participate effectively in and lead a team environment, including cross-functional teams.

  • Attention to detail, safety, quality and customer requirements.

  • Proficiency with MS Office products (specifically Word, Outlook, and Excel).

 

 

Eligibility Requirements\:

 

  • Must be legally authorized to work in the United States without restriction.

  • Must be willing to take a drug test and post-offer physical (if required)

  • Must be 18 years of age or older

 

 

Who We Are\:

 

At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more?  Visit boehringer-ingelheim.com and join us in our effort to make more health.


Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. 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.