QA Manager, Biotech: Quality & Audit Lead

Regulatory Jobs; Princeton (NJ); In loco; USD 139.000 - 163.000; Tempo pieno

Descrizione del lavoro

Summit Therapeutics Inc. is seeking a QA Manager to oversee the Product Complaint program for clinical and commercial materials. This role ensures audit readiness, supports inspections, and authors/updates QTAs and SOPs.

You will manage complaint investigations, CAPAs, and coordination with Pharmacovigilance, while driving process improvements in a fast-paced biotech environment across multiple sites, including NJ and FL offices.

Competenze

• Bachelor’s degree in chemistry, biochemistry, biotechnology, or other related life science discipline.
• Minimum of 5+ years of relevant experience.
• Experience managing product complaints.
• Strong knowledge of FDA, EMA, MHRA, ICH, PIC/S and international GMP/GDP regulations governing clinical and commercial biologics.
• Experience serving as an auditor in both internal and external audits.
• Experience reviewing and approving QTAs.
• Experience working with CMOs.
• Excellent communication skills both oral and written.
• Ability to work in a fast paced environment and efficiently manage projects and timelines.
• Experience working individually and within a team while balancing priorities.
• Attention to detail, accuracy, and thoroughness expected in all aspects of work.
• Self-motivated with a strong sense of work ethic.

Mansioni

• Serve as the liaison for our commercial product complaint call center and also manage clinical product complaints.
• Ensure product complaints are investigated and resolved, in accordance with internal requirements and regulatory expectations.
• Support product compliant reconciliation with the call center and Pharmacovigilance.
• Continuously improve the internal product complaint program in accordance with applicable laws and regulations.
• Serve as Auditor for internal audits and external audits.
• Ensure internal and external audit responses and appropriate CAPAs are identified and managed through to resolution in a timely manner and deliverables are met.
• Continuously improve internal and external audit programs to remain current with applicable laws and regulations.
• Provide support for the initial review, periodic review, and revision of Summit QTAs.
• Write, revise, review and/or approve SOPs and other controlled documents.
• Ensure issues are identified and managed through resolution in a timely manner, management is notified, and deliverables are met.
• Participate in developing, reporting, reviewing and trending of quality and performance metrics, including in support of Annual Product Reviews (APRs).
• Support GMP inspection readiness activities.
• All other duties as assigned.

Conoscenze

Excellent communication

Attention to detail

Self-motivated

Time management

Team collaboration

Formazione

Bachelor’s degree in chemistry/biochemistry/biotechnology

Strumenti

eQMS

QTAs

SOP development

Descrizione del lavoro

Summit Therapeutics Inc. is seeking a QA Manager to oversee the Product Complaint program for clinical and commercial materials. This role ensures audit readiness, supports inspections, and authors/updates QTAs and SOPs.

You will manage complaint investigations, CAPAs, and coordination with Pharmacovigilance, while driving process improvements in a fast-paced biotech environment across multiple sites, including NJ and FL offices.