External Quality Site Lead, GMP Biopharma

ACTalent; Parsippany-Troy Hills (NJ); Hybrid; USD 80.000 - 90.000; Vollzeit

Benefits dieser Stelle

Medical benefits

401(k)

Paid time off

Life Insurance

Zusammenfassung

Actalent is seeking a Quality Systems Specialist III to serve as the Quality Site Lead for external manufacturing and testing organizations in a hybrid role based in Parsippany, NJ or Foster City, CA. You will provide risk-based quality oversight across development, transfer, validation, launch, and supply, and lead quality governance with external partners.

The role requires a strong background in GMP, CAPA, and change control, plus experience with biologics/parenterals.

Qualifikationen

• 5+ years of relevant experience and a bachelor's degree in science or a related field, or 4+ years with an advanced science or business degree.
• Experience in Quality Assurance, Quality Control, manufacturing, validation, or another GMP‑regulated function within biopharmaceuticals.
• Working knowledge of GMP manufacturing processes including testing, packaging, labeling, validation, and batch documentation.
• Ability to oversee quality oversight of contract manufacturing or testing organizations.
• Experience with quality system elements such as validation, CAPA, deviation management, change control, and inspection readiness.
• Experience with parenteral, aseptic, and/or biologics operations is preferred.

Aufgaben

• Serve as the Quality Site Lead for assigned external manufacturing and testing organizations.
• Provide routine, risk-based quality oversight across development, technology transfer, validation, launch, and commercial supply.
• Implement the external quality plan for assigned sites in alignment with product, network, regulatory, and supply objectives.
• Monitor contract organizations' compliance with internal standards and regulatory requirements.
• Represent Quality on cross-functional teams including CMC, development, and supply.
• Coordinate development, implementation, and maintenance of Quality Agreements across manufacturing and testing.

Kenntnisse

Quality Assurance

Quality Control

GMP Compliance

Regulatory Knowledge

Risk Management

Cross-functional Collaboration

Ausbildung

Bachelor's degree in science or related field

Advanced degree preferred

Jobbeschreibung

Actalent is seeking a Quality Systems Specialist III to serve as the Quality Site Lead for external manufacturing and testing organizations in a hybrid role based in Parsippany, NJ or Foster City, CA. You will provide risk-based quality oversight across development, transfer, validation, launch, and supply, and lead quality governance with external partners.

The role requires a strong background in GMP, CAPA, and change control, plus experience with biologics/parenterals.