The Quality Sr. Specialist II will organize and execute aspects of GMP implementation at the East Norriton manufacturing facility. The successful candidate will possess an understanding of cGMP, specifically building and maintaining quality systems in support of sterile/gene therapy/cell therapy manufacturing. In addition, the ideal candidate must have a proven track record self-situational leadership by way of project leadership or direct supervision of staff.
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.
Coordinate and execute QA support activities within Manufacturing Operations.
Review deviations, change controls and/or CAPAs, as needed.
Review batches manufactured at East Norriton, as needed.
Author and review technical documents including but not limited to SOPs, various quality reports.
Release batches manufactured at East Norriton, as needed.
Managing the Materials Release Program and escalating issues, as needed.
Participate in computer system validation activities, as needed.
Mentor, coach and train Quality Associates in the QA Operations Team
Preferred Experience, Education & Qualifications
B.S. in a relevant discipline (medical, biochemistry, biology, biochemical engineering, or related field).
7-10 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.