Senior Manager, Quality Assurance GMP

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide scientific leadership for Quality Control (QC) Good Manufacturing Practice (GMP) activities, encompassing method transfer, qualification, validation, and lifecycle management for drug substance (DS) and drug product (DP).

• Act as a QC subject-matter expert in support of release and stability testing, including data review, trending, and interpretation.

• Lead or assist in the investigation of deviations, out-of-specification (OOS), and out-of-trend (OOT) results, including conducting root cause analysis and developing corrective and preventive actions (CAPAs).

• Work closely with Analytical Development and Chemistry, Manufacturing, and Controls (CMC) teams to facilitate successful method transfers to QC laboratories and external Contract Manufacturing Organizations (CMOs).

• Oversee QC activities carried out at contract testing laboratories and manufacturing partners, including data package review and ensuring adherence to quality and regulatory standards.

• Contribute to the creation and implementation of control strategies for small-molecule drug substances and drug products.

• Write, review, and approve QC-related documentation, such as methods, specifications, protocols, validation reports, and regulatory submission materials.

• Assist with regulatory inspections and audits, including preparation, response, and follow-up tasks.

• Identify areas for continuous improvement within QC processes, technologies, and compliance practices.

• Mentor junior staff and serve as a technical resource across various functional teams.

⛳️ Requirements

• Ph.D. in Chemistry, Pharmaceutical Sciences, or a related field, with extensive experience in QC or analytical sciences within a GMP setting; or an M.S./B.S. with considerable relevant industry experience.

• 5-8 years of experience in QC testing and GMP compliance, supporting clinical and/or commercial programs.

• Strong proficiency in analytical techniques pertinent to small-molecule pharmaceuticals (e.g., HPLC/UPLC, GC, dissolution, spectroscopic methods, and wet chemistry).

• Comprehensive understanding of method validation, transfer, and lifecycle management in a regulated environment.

• Proven experience in supporting or leading deviation investigations (OOS/OOT) and CAPA processes.

• Familiarity with global regulatory standards, including FDA, EMA, ICH guidelines, and compendial standards (USP, EP).

• Experience working with and supervising external laboratories, CMOs, or Contract Research Organizations (CROs).

• Demonstrated ability to work independently, manage multiple priorities, and influence cross-functional stakeholders.

• Excellent written and verbal communication skills, with the capability to clearly present technical concepts and data.

🏝️ Benefits

• Health insurance

• 401(k) match with immediate vesting

• Generous paid time off

• 12 weeks of fully paid parental leave

• Paid family and medical leave for all employees

• Company-paid short-term disability coverage for up to 20 weeks

• Wellness programs

• Tuition reimbursement

• Inclusive family-forming support