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Quality Assurance Operations Manager

Employer
Resilience
Location
East Norriton, PA
Start date
Nov 9, 2022

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Discipline
Manufacturing & Production, Operations, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country
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Job Details

Position Summary & Role (general description of the role; e.g. expectations, key milestones, impact)

The Quality Assurance Operations Manager will organize and execute aspects of GMP implementation at the East Norriton manufacturing facility. The successful candidate will possess an understanding of cGMP, specifically maintaining quality systems and compliance in support of sterile/gene therapy/cell therapy manufacturing.

Job Responsibilities (core responsibilities; include people management if applicable)

  • Work collaboratively with internal stakeholders and as necessary external partners/vendors to execute within a world-class GMP Quality Program.
  • Build strong relationships and collaborate closely with CMC/Operations/Development teams and other relevant groups to ensure the manufacturing and testing operations will comply with all US and International regulatory expectations.
  • Serve as a subject matter expert in GMP and provide technical expertise for QA operations.
  • Accountable for the QA Shop Floor activities having Quality oversight of GMP operations in the manufacturing and warehouse areas including but not limited to:
    • Ensuring compliant operations, maintaining an inspection ready state
    • Serving as first-line for notification, triage support, immediate action approvals, containment approvals, guidance for event handling
    • Performing changeover / clearances
    • Coordinate and execute QA support activities within Manufacturing Operations.
  • Serve as client communication liaison and collaborate with client persons in plant as required
  • Review and approve deviations, change controls and/or CAPAs, as needed.
  • Review of Aseptic Qualification, Technical Transfer and Engineering run documents.
  • Review and release batches manufactured at East Norriton, as needed.
  • Author and review technical documents including but not limited to SOPs, various quality reports.
  • Support supplier complaint management process.
  • Oversight of Material Release Program.
  • Review and approval of Method Qualifications, Laboratory Investigations and Environmental Monitoring.
  • Coach, mentor and develop the QA Operations personnel, ensuring robust coverage of skills and capabilities for QA Oversight of operations.
  • Participate in computer system validation activites, as needed.
  • Additional responsibilities assigned, as needed.

Preferred Experience, Education & Qualifications (Education/Degrees/Certifications)

  • B.S. in a relevant discipline (medical, biochemistry, biology, biochemical engineering, or related field).
  • 5-10 years relevant life sciences quality experience within quality and/or quality related functions.
  • Demonstrated track record with the successful support of GMP manufacturing and testing environments.
  • Demonstrated quality experience and the ability to collaborate with and effectively influence others.
  • Demonstrate experience with gowning and following aseptic behaviors.
  • Specific experience with aseptic, cell therapy and/or viral vector manufacturing strongly preferred.
  • Comfortable in a fast-paced, collaborative environment, working with minimal direction and able to adjust workload based upon changing priorities.
  • Familiarity with electronic quality systems/software applications.
  • Familiarity with electronic laboratory and manufacturing execution systems.
  • Working knowledge of GLP/GCP and GxP Regulatory requirements.
  • Experience in preparation and participation in regulatory authority plant/site inspections.
  • Experience supporting biologics manufacturing preferred.

Other Ideal Personal Characteristics:

  • Comfortable in a fast-paced, collaborative company environment, working with minimal direction and able to adjust workload based upon changing priorities.
  • Excellent oral and written communication skills.
  • Performs with Integrity.
  • Ability to collaborate and manage conflict in a fast-pace environment, working across functions.
  • Experience in application of lean methodologies and operational excellence to continuously improve.

#LI-GJ1

Company

Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development. For more information, visit www.Resilience.com and follow us on Twitter @IncResilience 

Find Us
Website
Location
9310 Athena Circles
La Jolla
CA
92037
United States
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