Position Summary & Role (general description of the role; e.g. expectations, key milestones, impact)
The Client Project Lead will be a liaison between Clients and the Resilience Quality organization at the East Norriton manufacturing facility. The successful candidate will possess an understanding of cGMP, specifically in quality systems and quality operations in support of sterile/gene therapy/cell therapy manufacturing. The candidate will also possess project management skills set.
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 Clients as well as internally with the CMC/Operations/Development teams.
- Participate in all Client meetings and provide updates to Quality management.
- Be the lead for Quality on Client activities and communications.
- Organize and manage scheduling Client visits and audits, as needed.
- Provide oversight over all Client change requests and providing all client notifications for quality records.
- Review and approve deviations, change controls and/or CAPAs, 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.
- 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.
- Experience working with Clients.
- Demonstrates project management skills.
- 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.