What are the responsibilities and job description for the Quality Control Manager, PCT & CQV position at WuXi Biologics?
Position title: Quality Control Manager, PCT & CQV
Work location: Cranbury, NJ (onsite 5 days a week). Laboratory and office-based role.
Job Summary
The QC Physiochemistry Lead is responsible for the strategic and operational leadership of physiochemical testing in support of clinical and commercial biologics manufacturing. This role oversees method execution, data integrity, investigations, and continuous improvement while managing and developing a high‑performing QC team. The position serves as a key scientific and quality partner to Manufacturing, QA, Regulatory, and Client Program teams.
Responsibilites
The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.
Work location: Cranbury, NJ (onsite 5 days a week). Laboratory and office-based role.
Job Summary
The QC Physiochemistry Lead is responsible for the strategic and operational leadership of physiochemical testing in support of clinical and commercial biologics manufacturing. This role oversees method execution, data integrity, investigations, and continuous improvement while managing and developing a high‑performing QC team. The position serves as a key scientific and quality partner to Manufacturing, QA, Regulatory, and Client Program teams.
Responsibilites
- QC Operations and Compliance:
- Provide leadership and oversight for daily QC Physiochemistry opertations.
- Ensure all testing activities are conducted in compliance with cGMP, CLP, CFR, and internal SOPs.
- Lead and oversee data review, investigiations, deviation, and CAPAs.
- Serve as site Subject Matter Exper (SME) for physicocheical testing and related investigations.
- REview and approve laboratory documentations, including notebooks, worksheets, protocols, and final reports.
- Drive continuous improvement of QC Process, 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 qualifiication of personnel.
- Promote a culture of qualit, accountability, and scientific excellence.
- Serve as a QC Lead or key contributor in client meetings related to testing, deviations, or investigations.
- Parner with QA and Regulatory teams to support filings and responses.
- Communicate effectively with Manufacturing and Technical teams to ensure timely testing support.
- 7 years of QC expereince in the pharmaceutical or biopharmaceutical industry with a Bachelor's degre, 5 years with a Master's degree.
- Proven experience supporting clinical and/or commercial manufacturing environments.
- Previous leadership experience.
- Strong working knowledge of QC operations forbiologics, including method execution, data review, and laboratory compliance.
- 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 ot analyze ocmplex 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 use and oversight of advanced analytica linstrucmentation and laboratroy systems such as LIMS, Empower, etc.
- Ability to critically evaluate method performance, trends, and assay suitability.
- Demonstrated people-management experience in a QC or biomanufacturing environment.
- Ability to coach, develop, and engage scientific staff.
- Strong cross-functional collaboaration skills across QC,QA, Manufacturing, MSAT, Regulatory, and Client teams.
- Abilitiy to communicate clearly with internal stakeholders and external clients.
The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.
Salary : $73,000 - $128,000