Senior Manager, Quality Operations - Biologics at Jobot
Raleigh, NC 27610
About the Job
Bonus + Equity + 401(k) + REMOTE
This Jobot Job is hosted by: Katie Griffith
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $145,000 - $165,000 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?
Job Details
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
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
This Jobot Job is hosted by: Katie Griffith
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $145,000 - $165,000 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
- REMOTE
- Health Benefits
- Commercial drug
Job Details
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
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
Salary
145,000 - 165,000 /year