Senior Operations QA Manager - ClinicalExelixis Inc.Alameda, CA
The Senior Operations QA Manager- Clinical is accountable for the QA oversight of day-to-day end-to-end (Drug Substance, Drug Product, Finished Goods) GMP Operations at the Contract Manufacturing Organizations (CMOs) that manufacture and test Exelixis development and clinical products, including batch record review, assessment, rapid escalation and issue resolution, release per supply plans, managing product complaints. This individual represents QA as the QA Partner (Primary Point of Contact), is the speaking One Voice for Quality for Exelixis business stakeholders, represents QA in an outwardly and business-facing capacity, in strategic and decision forums, and triages communication between Exelixis business functions, internally or externally, and QA, to provide and ensure delivery on company core goals and pipeline deliverables. The Senior Operations QA Manager- Clinical manages Exelixis partnerships, collaborations, audits, forges strong relationships to maintain performance and continuous improvement, and demonstrates a high level of independent quality judgment and acumen. ESSENTIAL DUTIES AND RESPONSIBILITIES: Represent QA as the QA Partner (Primary Point of Contact) (vendors, CMOs, development collaborators for contracts, validation, change management, GMP issues). Maintain and continuously improve QA programs, policies and procedures to ensure GMP compliance of commercial and clinical trial material. Perform record review, and batch disposition for commercial and clinical trial material, including comprehensive Quality assessment. Oversee CMOs: Issue/deviation management, CAPAs with vendors and cross-functional teams to resolve potential product quality issues, rapidly escalate and resolve issues. Generate, review/approve internal and external GMP records (MBR and EBR (master and executed batch records), stability reports/protocols, specifications, deviations, change controls, testing and labeling/packaging records, development/CMC documents submitted to regulatory agencies, etc.) Maintain and report CMO metrics and QA metrics. Identifies and rapidly mitigates risk. Contribute to APQR (annual product quality review) as applicable. Lead implementation of process and system improvements as applicable. Support implementation of quality systems, department and corporate procedures to ensure compliance with cGMPs. Evaluate and generate data to support KPIs (Key Performance Indicators) Understands regulatory requirements. Assists monitoring current and proposed quality and scientific issues and advises management of events critical for Exelixis. Delivers per supply plans and drives for results. SUPERVISORY RESPONSIBILITIES: None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of related experience; or, Master's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 7 years of related experience; or, PhD in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 2 years of related experience; or, Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: A minimum of 8 years of related QA experience or the equivalent combination of experience and education/training. Experience in the biotech or pharmaceutical industry, and clinical packaging/labeling activities is preferred Two years of experience managing Contract Manufacturing Organizations preferred Five years of relevant experience in the biotech/pharmaceutical industry. Experience in the development of metrics and continuous improvements is preferred Knowledge/Skills: Working knowledge of the end-to-end commercial and clinical manufacturing and quality processes, including US/EU regulations affecting the pharmaceutical industry, and ICH guidelines. Proven experience in a virtual manufacturing environment or relevant industry/profession. Requires a broad range of knowledge and experience with biologic and chemical processes, drug development, analytical testing methods, and understanding of the international regulatory landscape. Small molecule, oral solid form, biologics technical knowledge required. Uses broad expertise or unique knowledge and skills to drive meeting company core objectives and principles, and to achieve goals in creative and effective ways. Implements technical solutions within quality requirements to complex problems. Interprets, executes and recommends modifications to companywide policies and/or divisional programs. Great attention to detail. Applies strong analytical and business communication skills. Evaluates and generates data to support departmental metrics.•Excellent written, verbal and presentation communication skills, able to translate complex concepts across all levels of the organization. Excellent MS Office, Word, Excel and PowerPoint skills. WORKING CONDITIONS: This is an onsite position Travel as required #LI-HG1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $140,000 - $199,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Posted 1 day ago