New · posted Oct 30
Exelixis · Biotechnology
Operations QA Manager - Commercial
- Alameda, CA
- On-site
- Full-time
- Manager
The role
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 escalate risks to products.
What you need
Two ways to qualify
Bachelor’s
+ 7+ years of experience
BS/BA degree in related discipline and a minimum of 7 years of related experience; or,
- or
Master’s
+ 5+ years of experience
MS/MA degree in related discipline and a minimum of 5 years of related experience; or,
Education/Experience
- PhD in related discipline and 0 or more years of related experience; or,
- Equivalent combination of education and experience.
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.
Experience/The Ideal for Successful Entry into Jobnice to have
- Experience in the biotech or pharmaceutical industry is required.
- Experience in CMO oversight is preferred.
What you'll do
- 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
Pay and benefits
$145,000 – $183,000 a year
Employer provided401k plan with company contributions
Medical, dental and vision coverage
Life and disability insurance
Discretionary annual bonus
Employee stock purchase opportunity
15 vacation days and 17 paid holidays
Where you'll work
Alameda, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Alameda, CAWorking conditions
- Onsite position
- Travel as required
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.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.
If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [email protected].
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.
Equal opportunity, accessibility and legal noticesExelixis's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 30, 2026
Salary intelligence
How the pay compares
This role's midpoint is 9% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in California28 roles publishing pay
Manager roles in the US123 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $145,000 | — | $183,000 |
| California (middle half) | $157,125 | $165,500 | $181,000 |
| All US (middle half) | $129,000 | $150,000 | $166,000 |
This role: Exelixis's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 30, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 988 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Exelixis's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 35 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs9
- GMP and compliance5
- Collaboration and leadership5
- Lab testing and methods4
- Regulatory submissions3
- Investigations and CAPA1
- Validation and qualification1
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Exelixis on Regulatory Jobs
- 8
- Open roles
- 8
- Distinct roles
- 1
- Locations
By discipline
- Quality5 63%
- Regulatory3 38%
By level
- Director5 63%
- Manager2 25%
- VP & Executive1 13%
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Operations QA Manager - Commercial at Exelixis
Open until filled. $145K–$183K a year, employer provided.