Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheim's Biologics Business Unit. We are a fully integrated biologics operation with over 500 scientist and specialists, covering cutting edge early- to late stage CMC development, clinical and commercial drug substance and drug product manufacturing, medical device assembly for combination products and packaging operations.
We are continuing our rapid growth, investing over $200m into the expansion of our capacity and capabilities, and creating approximately 200 new jobs.
Driving this growth is an exciting pipeline of multiple Boehringer Ingelheim novel biologic entities (NBEs) and biosimilars, as well as, a growing diverse portfolio of therapeutics we develop and manufacture for other leading pharma and biotech companies. This includes multiple commercial product launches planned over the next couple of years, for which we can tap into Boehringer Ingelheim's unique experience of having brought 30 biologics to market globally.
Leveraging our diverse talent pool, we are also driving technology and innovation globally, through major investment and collaborations into next generation manufacturing platforms and technologies, which may change how biologics will be made in the future.
Whether we work on our own products, help partners to bring their products to market or innovate new technologies and approaches - Everything we do, we do to help patients!
This position works independently to provide QA oversight of Fremont site Quality Control (QC) processes according to cGMP regulations. Also responsible for implementing, maintaining, and monitoring Quality processes necessary for that assurance. This includes timely identification, investigation, and resolution of events impacting product quality. QC oversight responsibilities include ensuring adherence to SOPs, providing concurrence on corrective and preventive actions (CAPA), deviation management, providing quality approval of impact assessments for changes to equipment and processes, risk management, ensuring that documentation and investigations meet compliance requirements, and providing support for lot disposition. The incumbent will ensure that Quality decisions are made, with consultation from Quality colleagues, which may have a direct impact on active manufacturing operations, release of equipment/systems/areas, and batch disposition.
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:
Support Data Integrity initiatives at the site, including Periodic Audit Trail reviews of QC equipment.
Support QA Disposition of BI and client products by review and approval of QC disposition elements (test record reviews, CofA approval, CofC, EM assessments etc.)
Review and approval of QC Standard Operating Procedures and Change Controls to ensure compliance with cGMP requirements.
Participate in audits as SME, prep room staff or Inspection room staff
Collaboration on responses to any observations
Supports regulatory audits, internal audits and customer audits.
Ownership of CAPAs related to audits to ensure timely completion.
Oversight and approval of QC deviation and OOX investigations.
Executes process and procedural changes to improve QA process performance, robustness, and efficiency. This may include any of the quality systems within the plant (for example: Document Review, Deviations, CAPA, Change Management, Training, Lot Disposition, QC Right First Time/Documentation).
Ensures compliance with and performs all company business in accordance with Government (cGMP, FDA, DEA, OSHA, Safety) and Company Policies, Procedures, Goals and Objectives. May participate in BI interactions with various governmental agencies/regulators and external auditors.
Bachelors degree from an accredited institution in Science (Chemistry, Biochemistry, Microbiology or other equivalent Life Science Degree)
Four (4) years of relevant work experience in Quality in a highly regulated Pharma environment
Strong ability to communicate in an open, customer-focused manner.
Exercise independent judgment and decision making abilities
Demonstrated problem-detection and problem-resolution skills
Ability to facilitate conflict resolution and negotiation skills
Excellent verbal and written communication skills; good interpersonal skills
Must possess demonstrated organizational skills that have proven results in the ability to be self-directed
Experience with Quality standards.
Experience in 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.
Demonstrated experience working on projects independently
Ability to adapt and be flexible with project changes as well as a continuously-improving work environment.
Experience in maintaining accurate and factual hard-copy and electronic records.
Work and participate effectively in a team environment, including cross-functional teams.
Attention to detail, safety, quality and customer requirements.
Proficiency with MS Office products (specifically Word, Outlook, Powerpoint and Excel).
Expertise in the creation and administration of SOPs, concurrence on corrective and preventive actions (CAPA), deviation management, approvals of impact assessments for changes to equipment and processes.
Knowledge of release of equipment/systems/areas, and batch disposition.
Knowledge of and experience in QA Disposition activities
Experience in assessing risks and ensuring that documentation and investigations meet compliance requirements
Knowledge and experience in Data Integrity
Knowledge of relevant regulations and guidelines (e.g. cGMPs, SOPs, protocols)
Understanding of Quality Assurance specifications and process
Experience reviewing and approving QC release documents (e.g. CofA, test records,testing reports, Product Specification Files)
Knowledge of regulatory requirements and quality and compliance standards
Experience in creating site QA policies and practices
Experience in creating and implementing department-wide business practices
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, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC, and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable law.