Quality Control Manager, PCT

Responsibilities

• Provide leadership and oversight for daily QC Physiochemistry operations.
• Ensure all testing activities are conducted in compliance with cGMP, GLP, CFR, and internal SOPs.
• Lead and oversee data review, investigations, deviations, and CAPAs.
• Serve as site Subject Matter Expert (SME) for physiochemical testing and related investigations.
• Review and approve laboratory documentation, including notebooks, worksheets, protocols, and final reports.
• Drive continuous improvement of QC processes, efficiency, and right-first-time execution.
• Identify and mitigate risks related to method performance, capacity, and compliance.
• Support site readiness for regulatory inspections and client audits.
• Supervise, mentor, and develop QC staff; conduct performance management activities.
• Ensure appropriate training and qualification of personnel.
• Promote a culture of quality, accountability, and scientific excellence.
• Serve as QC lead or key contributor in client meetings related to testing, deviations, or investigations.
• Partner with QA and Regulatory teams to support filings and responses.
• Communicate effectively with Manufacturing and Technical teams to ensure timely testing support.

Qualifications

• Minimum 3-5 years of hands on experience with HPLC, CE, ICIEF.
• Minimum 1-2 years of previous management experience with direct reports.
• 3+ years of QC experience in the pharmaceutical or biopharmaceutical industry.
• Proven experience supporting clinical and/or commercial manufacturing environments.
• In-depth understanding of global regulatory requirements and guidance, including cGMP, FDA, EMA, ICH, and major pharmacopeias.
• Experience supporting IND, BLA, and post‑approval regulatory filings.
• Demonstrated competency in investigations, root cause analysis, and CAPA.
• Ability to analyze complex data sets and make sound, risk-based decisions.
• Proven capability to balance strategic planning and hands-on execution.
• Excellent written and verbal communication skills.
• Strong organizational skills with the ability to manage competing priorities.
• Comfortable working in a fast-paced, client-facing environment.
• Flexibility to support some evening or global conference calls.
• Strong scientific understanding of protein and biologics analytical methods, including but not limited to: HPLC/UPLC, Capillary Electrophoresis (CE-SDS, icIEF), Identity methods, Protein Concentration methods.
• Proficiency in the use and oversight of advanced analytical instrumentation and laboratory systems such as LIMS, Empower, etc.
• Ability to critically evaluate method performance, trends, and assay suitability.

Skills

• Leadership and collaboration skills.

Benefits

The anticipated salary range for this position is $73,000 - $155,000.