Senior Manager, GMDP Audits

About the position

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario. The Senior Manager, GMDP Audits conducts audits, including but not limited to external suppliers (CDMOs, DS manufacturers, batch release sites, warehousing and transportation service providers, distributors, etc), internal manufacturing sites, commercial affiliates, as well as other entities as applicable, according to KK standards. This includes routine, for cause and due diligence audits.

Responsibilities

• Performs GMP/GDP due diligence audits, globally.
• Performs, as lead auditor or coauditor, GMP/GDP audits, including but not limited to external suppliers (CDMOs, DS manufacturers, batch release sites, warehousing and transportation service providers, distributors, etc), internal manufacturing sites, commercial affiliates, as well as other entities as applicable.
• Evaluates Audit responses and oversees tracking mechanism for GMP/GDP audits and manages CAPA as per KK standards.
• Provides input to the annual risk-based audit plan, Schedule and execution of audits based on changing business environment and interaction with cross-functional teams.
• Provides ongoing feedback to management on potential quality-related risks.
• Supports (and may lead) process improvement initiatives, develops/administers SOPs, as well as maintenance of other controlled documents in the quality document management systems.
• Participates in Health Authority inspection activities (both domestic and international, as applicable).

Requirements

• Life Science degree or equivalent (preferably in Pharmacy, Chemistry or Microbiology).
• 5 years' (minimum) experience of working within the pharmaceutical industry's manufacturing, of which at least 3 should have involved Quality Assurance work and/or GMP/GDP auditing.
• Aseptically manufactured parenteral products experience is required.
• Excellent working knowledge of the basic principles of pharmaceutical quality, quality assurance, manufacturing process quality.
• Sound knowledge of the regulatory requirements, science and manufacture behind pharmaceutical dosage forms (e.g. oral solid and semi-solid dosage forms, oral liquid and intravenous sterile / aseptically-manufactured products).
• Proficient in MS Office Suite.

Nice-to-haves

• Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly.
• Strong interpersonal and communication skills.
• Strong work ethic is required.
• Detail oriented and excellent follow through.
• Ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment.
• Passion for personal learning and development to be able to grow with the company.
• Cultural sensitivity and ability to develop consensus within a multinational organization.