Position:Senior Manager, Analytical Quality Assurance
Location:Brisbane, CA (Hybrid - 2 days onsite)
Length:9+ months
*W2 Candidates Only, No C2C
Job Description:
Our client is seeking a highly motivated and experienced Senior Manager for their Analytical Quality Assurance (QA) team. This role will support quality control activities in early and late-phase clinical, as well as commercial stage development and production. The Senior Manager will work closely with cross-functional teams including CMC Quality Assurance, Analytical Development, CMC Quality Control, and other departments involved in the development of biologics and small molecules. The ideal candidate will bring a strong background in quality assurance, analytical methods, and regulatory compliance in a CBER/CDER regulated environment.
Essential Duties and Responsibilities (but not limited to):
- Provide QA oversight for analytical method lifecycle activities, including development, validation, transfer, verification, performance monitoring, and documentation (i.e., method reports, validation studies, SOPs, reagent qualification, and stability protocols).
- Support change management processes and lead investigations for deviations, OOS, OOE, and OOT events.
- Review CMC-related regulatory documentation (i.e., BLA, IND, etc.) to ensure compliance with FDA, EMA, ICH guidelines, and internal policies.
- Collaborate with cross-functional teams to establish quality agreements with contract testing laboratories and contribute to root cause analysis and risk assessments.
- Ensure all activities meet regulatory requirements and industry best practices while supporting both pre-clinical and commercial product development.
Qualifications:
- Bachelor's degree or equivalent experience in Quality Control or a related field.
- Minimum of 1 year of experience in QA and at least 5 years of experience within a regulated industry (CBER/CDER), with expertise in cGMPs.
- Experience supporting analytical development and QC in biologics and small molecules (i.e., compendial methods, HPLC, CE, GC, SDS-PAGE, and NMR).
- Proven experience managing relationships with contract testing labs and Contract Manufacturing Organizations (CMOs).
- Strong interpersonal skills with the ability to collaborate effectively within a team environment.
- Excellent analytical and systematic thinking skills.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
- Familiarity with Electronic Quality Management Systems (eQMS), such as Veeva, is required.
- Experience establishing quality agreements with contract testing laboratories is a plus.
- Knowledge of statistical tools for data analysis and trending is highly desirable.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
Make this your next career move as one of our many long-term contractors or employees!
- Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
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- 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 'Employee's Choice - Best Places to Work' by Glassdoor.
- Voted 'Best Staffing Firm to Temp/Contract For' seven times by Staffing Industry Analysts as well as a 'Best Company to Work For' by Forbes, Fortune and Inc. magazine.
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Digital Prospectors
Mar 10, 2025