Senior Manager, Quality Operations (Biologics)
Senior Manager, Quality Operations (Biologics)
Jobot
Staten Island, NY
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Jobot provided pay range
This range is provided by Jobot. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$130,000.00/yr - $160,000.00/yr
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Job details
Bonus + Equity + 401(k) + REMOTE
This Jobot Job is hosted by Katie Griffith
Are you a fit? Easy Apply now by clicking the "Easy Apply" button and sending us your resume.
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?
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 CMO’s 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
Interested in hearing more? Easy Apply now by clicking the "Easy Apply" button.
Want to learn more about this role and Jobot?
Click our Jobot logo and follow our LinkedIn page!
Job details
Bonus + Equity + 401(k) + REMOTE
This Jobot Job is hosted by Katie Griffith
Are you a fit? Easy Apply now by clicking the "Easy Apply" button and sending us your resume.
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
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 CMO’s 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
Interested in hearing more? Easy Apply now by clicking the "Easy Apply" button.
Want to learn more about this role and Jobot?
Click our Jobot logo and follow our LinkedIn page!
-
Seniority level
Not Applicable -
Employment type
Full-time -
Job function
Management and Manufacturing -
Industries
Biotechnology Research, Research Services, and Nanotechnology Research
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