Manager, Quality Assurance

Company: Boehringer Ingelheim
Location: Fremont
Posted on: November 14, 2021

Job Description:

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! #LI-MS1 *I-SF1 #PDN1 Description: This position is responsible for ensuring compliance of Fremont site manufacturing processes according to cGMP regulations. Also responsible for implementing, maintaining, and monitoring 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 that will drive Fremont's business performance and Quality innovation. Incumbent provides technical expertise on Quality Assurance standards and processes to team members. 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 and manages the work of the BI Fremont Quality Assurance group; contributes to 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 resolution. * 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. This may include any of the quality systems within the plant (for example: Document Review, Deviations, CAPA, Change Management, Training, Lot Disposition). * 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 and contributes to department-wide business practices Requirements: * Requires a Bachelor's or higher degree from an accredited institution preferably in sciences. * Requires a minimum of five (5) years of experience working in the Quality related aspects of a life sciences or closely related industry. * Requires one to three (1-3) years of project management and other relevant leadership experience, including experience managing within complex matrix organizations and projects. * Related work experience auditing (internal/supplier) in a cGMP environment * Demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function. * Strong understanding and appreciation for regulatory requirements and quality and compliance standards under which the Fremont site is operating * Negotiating skills * Overall understanding of Quality Assurance specifications and process * 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. * Ability to manage a major Quality system such as Deviations, Auditing or Change Control * 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. '629276

Keywords: Boehringer Ingelheim, Fremont , Manager, Quality Assurance, Executive , Fremont, California