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Job details…
Bonus + Equity + 401(k) + REMOTE
This Jobot Job is hosted by Katie Griffith
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Salary $130,000 – $160,000 per year
A Bit About Us
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.
Why join us?
Competitive Salary
Annual Bonus
Equity (RSUs)
401k Program
REMOTE
Health Benefits
Commercial Drug
Job Details
We are looking for a 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
Support internal and external stakeholders with DSCSA and Distribution activities
Work with Quality Systems and CMC team to ensure quality and technical documentation is delivered to the internal archiving system
Facilitate new supplier intakes, supplier qualifications, and update and maintain Quality Agreements with suppliers
Provide guidance, advice, and support for GMP quality and compliance
Represent Quality as PIP at CMOs as necessary to support production operations.
Travel 10% 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
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
Knowledge of cell-based or gene therapies is desired.
Knowledge of medical device and combination product is desired.
Knowledge of DSCSA requirements is desired.
Excellent attention to detail, organizational and time management skills,
Strong written and oral communication skills
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