Senior Manager, Quality Operations - Biologics

We are a rapidly growing therapeutics company with an approved drug on the market, leveraging scientific advances in B-cell biology to develop novel treatment for patients.

We are looking for a Manager/Senior Manager of Quality Operations to help provide quality oversight for our biologics commercial and clinical development programs.

Responsibilities:
– Oversee CMO to ensure products manufactured are produced in accordance with regulatory requirements, product registrations, and quality agreements
– Perform batch record reviews and lot dispositions
– Conduct and review product and/or lot-related deviations, complaints, CAPAs, change controls and annual product quality reviews (APQRs).
– Review and approve controlled documents, including clinical and commercial manufacturing and packaging master batch records, protocols and final reports
– Work with Quality Systems and CMC team to ensure quality and technical documentation is delivered to the internal archiving system
– Provide guidance, advice, and support for GMP quality and compliance
– Represent Quality as PIP at CMO’s as necessary to support production operations.
– Travel 10-15% of time (domestic and international), including visits to CMOs and offices in NC, NJ, and NY

Qualifications:
–– University degree in life sciences or related fields
–– 5+ years’ experience in GMP Quality or Manufacturing in biopharma/biologics/pharma industry
–– Must have experience in biologics.
–– Thorough knowledge of GMP regulations; direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections is a plus; direct interaction with qualified person (QP) is a plus
–– Experience supporting clinical phase through commercial and lifecycle management,
–– Experience in oversight of contract manufacturing,
–– Proficiency in electronic QMS Software such as Veeva, Trackwise, etc.
–– Excellent attention to detail, organizational and time management skills,
–– Strong written and oral communication skills