Sr. Manager, CQA GLP (Biotech)

TL;DR

Sr. Manager, CQA GLP (Biotech): Ensuring nonclinical studies comply with GLP regulations and Health Authorities' guidance with an accent on quality oversight of external vendors and laboratory processes. Focus on managing GLP quality systems, conducting audits of CROs, and maintaining inspection-readiness.

Location: Hybrid (Somerset, NJ, USA) - 2-3 days on-site required

Salary: $146,410 - $192,164 USD

Company

Global biotechnology company dedicated to treating and curing life-threatening diseases using advanced cell therapies.

What you will do

• Manage GLP quality compliance systems, including the implementation of policies, procedures, and standards.
• Perform and oversee audits of external vendors and CROs to ensure adherence to quality protocols.
• Oversee laboratory processes, support the development of SOPs, and review bioanalytical assays.
• Manage GCP/GLP deviations from study protocols or standard operating procedures.
• Collaborate with cross-functional teams to verify data integrity for nonclinical and clinical studies.
• Coordinate responses to regulatory agency questions resulting from inspections and audits.

Requirements

• Bachelor’s degree in biology, biochemistry, or life sciences.
• Minimum of 3 years of industry experience in Quality (for Sr. Manager level).
• 3 years of experience overseeing GLP Quality in laboratories testing biologics.
• Working knowledge of FDA and ICH GCP guidelines and GLP related regulations.
• Must be based in Somerset, NJ to adhere to the hybrid work schedule.
• English: Proficiency required for effective communication.

Nice to have

• Experience performing audits of GLP testing labs.
• Experience hosting regulatory audits.
• Experience working with CROs, vendors, and relationship management.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan with company match (vests on day one).
• 8 weeks of paid parental leave after 3 months of employment.
• Generous PTO including vacation, personal, sick time, and 11 company holidays.
• Flexible spending (FSA) and health savings accounts (HSA).
• Additional voluntary benefits including life, disability, and pet insurance.