Manager, Quality Control - Analytical

Revance; Newark (CA); Hybrid; USD 140,000 - 150,000; Full time

Benefits offered by this job

Competitive Compensation

Flexible PTO

Generous healthcare benefits

401k match

Wellness discounts

Job summary

Revance is looking for a Manager of Quality Control (QC) - Analytical in Newark, CA. You will lead analytical testing for clinical and commercial drug manufacturing in a GMP-regulated facility. This role involves ensuring compliance with regulatory standards and managing laboratory readiness for inspections.

With at least 10 years of experience and leadership in QC, candidates should possess a Bachelor's degree and demonstrate a strong background in biosecurity, analytical methods, and team development. The position is hybrid and offers competitive compensation and comprehensive benefits.

Qualifications

• 10+ years of directly related experience with a Bachelor's degree.
• 3-5 years of management experience.

Responsibilities

• Lead QC analytical testing activities.
• Ensure alignment of lab capacity with manufacturing timelines.
• Oversee analytical testing execution.
• Serve as key SME during regulatory inspections.

Skills

Leadership

Regulatory compliance

Analytical testing

Biosecurity oversight

Education

Bachelor's degree

Master's or Ph.D. in relevant fields

Job description

Job Summary

The Manager, Quality Control (QC) - Analytical is responsible for leading and overseeing the analytical testing program supporting both clinical and commercial drug substance (DS) and drug product (DP) manufacturing in a GMP‑regulated facility registered under the Federal Select Agent Program (FSAP). This role ensures compliant, secure, and timely laboratory testing aligned with global regulatory standards while maintaining strict adherence to select agent and toxin regulations.

This position combines leadership, technical expertise, regulatory compliance, and biosecurity oversight to support product release, stability, method lifecycle management, and laboratory readiness for inspections. The role works with key laboratory personnel and personnel from other functions, including Quality Assurance, Manufacturing, Supply Chain, and external CMOs and contract testing sites.

Reporting to: Executive Director, Quality Control

Location: Newark, CA - hybrid

Salary range: $140,000 - $150,000 + annual performance bonus

Responsibilities / Essential Duties

• Lead QC analytical testing activities supporting clinical and commercial DS and DP manufacturing, including: in‑process testing; release and stability testing; and raw material and excipient testing.
• Ensure alignment of laboratory capacity and scheduling with manufacturing timelines and supply chain demands.
• Oversee the execution of analytical testing for drug substance and drug product.
• Drive on‑time batch disposition for both clinical and commercial products.
• Maintain laboratory practices consistent with biosafety (BSL) and biosecurity requirements, including chain‑of‑custody and material accountability.
• Partner with the Responsible Official (RO) and biosafety teams to ensure inspection readiness for CDC/APHIS/FSAP audits.
• Oversee training and qualification of staff handling select agents.
• Review and approve test results and certificates of analysis (CoA); deviations, OOS/OOT investigations, and CAPAs; stability protocols and reports.
• Serve as key SME during regulatory inspections (FDA, EMA, CDC/APHIS).
• Provide oversight of analytical methods used for DS and DP.
• Lead method validation, verification, transfer, and lifecycle management across clinical and commercial phases.
• Support analytical investigations related to process deviations, product quality issues, and stability trends.
• Lead and develop a team of QC supervisors, analysts, and specialists in a regulated and high‑containment environment.
• Ensure personnel are fully trained and qualified in cGMP practices, analytical techniques, and biosafety and biosecurity practices.
• Promote a culture of safety, accountability, compliance, and operational excellence.
• Drive improvements in laboratory efficiency and turnaround times; method robustness and lifecycle management; and error reduction and right‑first‑time performance.
• Track and improve key performance metrics (KPIs).
• Ensure timely execution of QC deliverables to support release timelines.

Basic Qualifications

• Bachelor's degree & 10+ years' directly related experience.
• 3‑5 years' management experience.

Preferred Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or related discipline.
• Master's of Science or Ph.D. in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or related discipline.
• Direct experience working in a BSL‑2/BSL‑3 lab.
• Experience with a range of biological and physio‑chemical methods.
• Experience with regulatory inspections (FDA, EMA, CDC/APHIS).

Benefits

• Competitive Compensation including base salary and annual performance bonus.
• Flexible PTO, holidays, and parental leave.
• Generous healthcare benefits, HSA match, 401k match, employer‑paid life and disability insurance, pet insurance, wellness discounts and much more!

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job‑related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."

Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.