Operations QA Manager - Commercial

Exelixis Inc; Alameda (CA); On-site; USD 145,000 - 183,000; Full time

Benefits offered by this job

401k plan with generous company

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus program

Sales-based incentive plan

Opportunity to purchase company stock

Long-term incentives

Vacation and holidays

Job summary

Exelixis Inc. seeks an Operations QA Manager - Commercial to oversee end-to-end GMP operations at CMOs, including drug substance, product, renders, raw materials, packaging and labeling.

You will assess vendor processes and review batch records, partnering to mitigate risks to products from vendor sites and collaborators. The role requires strong GMP knowledge, regulatory understanding and the ability to drive quality programs across multiple facilities.

Qualifications

• BS/BA or MS/MA or PhD in a related field plus 5–7 years of experience, or equivalent.
• Experience in biotech/pharma and CMO oversight is preferred.
• Working knowledge of commercial and clinical manufacturing quality processes.
• Familiarity with US/EU regulatory guidance for pharmaceuticals.

Responsibilities

• Develops and maintains QA programs to ensure GMP compliance for commercial and clinical materials.
• Performs record reviews and disposition activities for material including QA assessments.
• Coordinates investigations with vendors and cross-functional teams to resolve quality issues.
• Oversees generation, review and approval of GMP documents and batch records.
• Supports vendor management for contracts, validation, changes, and QA issues.
• Implements quality systems and updates procedures to ensure GMP compliance.
• Monitors regulatory policies and advises on QA events to leadership.
• Authors work instructions and standard operating procedures; drives for results.

Skills

GMP knowledge

Vendor oversight

Quality systems

Regulatory understanding

Analytical skills

Excellent communication

Education

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

SUMMARY/JOB PURPOSE

The Operations QA Manager - Commercial is responsible for the QA oversight of end-to-end, day-to-day GMP Operations at the Contract Manufacturing Organizations (CMOs) that generate Exelixis products, including Drug Substance, Drug Product, Intermediates, Raw Materials, Packaging and Labeling. Assesses vendor processes, systems and procedures to evaluate their quality performance against established standards and regulatory requirements. Reviews batch records. Part of Exelixis partnerships and collaborations to identify, rapidly mitigate and escape risks to products.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Develops, establishes and maintains the QA programs, policies, and procedures to ensure GMP compliance of commercial and clinical trial material.
• Performs record review, and disposition activities for commercial and clinical trial material including conducting the comprehensive QA assessment.
• Coordinates investigations with vendors and interdepartmental teams to resolve potential product quality issues.
• Oversees the generation, review and/or approval of internal and external documents used in GMP activities.
• Provides support to the QA Partner to manage vendors, contract facilities and joint development collaborators for contracts, validation activities, change management and other QA issues.
• Supports the implementation of other quality systems, including departmental and corporate procedures, to ensure compliance with GMPs.
• Understands regulatory agency policies and guidance as it pertains to QA issues.
• Assists in monitoring current and proposed quality and scientific issues and advises supervisor on events for Exelixis.
• Provides support as needed for the review various quality review/approval documents such as, but not limited to, manufacturing, testing and labeling/packaging batch records, and CMC documents submitted to regulatory agencies.
• Authors work instructions and standard operating procedures.
• Drives for results.

SUPERVISORY RESPONSIBILITIES

None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS

Education/Experience: BS/BA degree in related discipline and a minimum of 7 years of related experience; or, MS/MA degree in related discipline and a minimum of 5 years of related experience; or, PhD in related discipline and 0 or more years of related experience; or, Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: Experience in the biotech or pharmaceutical industry is required. Experience in CMO oversight is preferred. Knowledge/Skills: Working knowledge of the commercial and clinical manufacturing and quality processes, including US and EU regulations affecting the pharmaceutical industry. Has extensive experience in a virtual manufacturing environment or relevant industry/profession. Small molecule technical knowledge, oral solid dosage form and biologics preferred. Familiarity with serialization is desired. Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways. Develops technical solutions to complex problems. Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results. Guides the successful completion of major programs, projects and/or functions. Interprets, executes and recommends modifications to companywide policies and/or divisional programs. Has complete understanding and wide application of technical principles, theories, concepts and techniques. Attention to detail when utilizing PC or reviewing documents and editing/proof-reading documents. Has extensive knowledge of other related disciplines. Applies strong analytical and business communication skills. Excellent verbal, written and presentation communication skills. Must be proficient in Word, Excel and PowerPoint.

WORKING CONDITIONS

Onsite position Travel as required #LI-HG1 Location: Alameda, CA Range for this position: $145,000 - $183,000

The base pay offered will take into account job-related knowledge, skills, experience and internal equity, among other factors.

• 401k plan with generous company contributions
• group medical, dental and vision coverage
• life and disability insurance
• flexible spending accounts
• discretionary annual bonus program
• sales-based incentive plan
• opportunity to purchase company stock
• long-term incentives
• 15 accrued vacation days in their first year
• 17 paid holidays including a company-wide winter shutdown in December
• up to 10 sick days throughout the calendar year

If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [e-mail].

WORKING CONDITIONS: Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

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. Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial. As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission. Cancer is our cause. Make it yours, too.