The Validation Lead will be responsible for the overall validation program for Beam’s GMP operations. The position is critical to the overall manufacturing facility operation and compliance for Beam, NC and will be located in RTP. The NC manufacturing facility is operational and will build out additional capacity in various phases over a 6-8+ year period, with a focus on advanced therapeutic manufacturing technologies (cell and gene therapy modalities). The facility is a clinical phase manufacturing plant with the intent to move several programs to commercial within the same facility. As this is a manufacturing site, the position is expected to be on site with some flexible work scheduling available.
Globally, the position will manage all standards, procedures and requirements for the Validation program and provide guidance / consultation for Cambridge teams and as such there will be travel required on periodic basis.
The Validation lead is responsible for managing a matrix team of Beam FTE and contract personnel for CQV execution at the NC site.
The Validation lead will coordinate closely with Engineering and Facilities to manage lifecycle for commissioned systems and coordinate work in support of change management for the site including document reviews and approvals.
The role will cover all aspects of validation including facilities, utilities, equipment and instrumentation as well as partnering with technical leaders for creation of cleaning validation and process validation programs as we progress in product lifecycle. The role will have ultimate responsibility to ensure that validation systems and processes are implemented to ensure compliance to Good Manufacturing Practices. The position will report into the RTP Site Quality Head.
- Provide leadership for the site on the various aspects of validation, which includes the managing master validation plan(s), equipment/instrument qualification, facility/utility qualification, cleaning validation, and other aspects of validation to ensure compliant operations.
- Responsible for the validation program, including policies, SOPs, plan(s), and others as required. This includes development, review, and approval of validation documents and supporting packages (e.g. Engineering turnover packages).
- Responsible for overall coordination with contract validation firm(s) for all validation activities in NC location.
- Responsible for management of external budget and spend related to facility validation efforts for NC location.
- Collaborate with all the GMP functions onsite and globally to provide continuous improvement of the validation program and support change management through review and assessment of changes.
- Responsible for providing status updates to management and others on the overall validation activities.
- Responsible for ensuring cGMP principles are implemented and adhered to during execution of validation related activities.
- Ensures projects are provided the suitable resource(s) to meet common goals and timelines.
- Ensures systems and equipment are compliant to all applicable regulatory guidelines and data integrity principles are adhered to, to provide confidence in the data generated.
- Compiles and reports data with appropriate interpretations for applicable management reviews, Annual Product Reviews, and all other required assessments.
- Ensures continuous improvement across the aspects of quality validation. .
- Bachelors or Advanced degree in a scientific discipline.
- 12+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
- 5+ years of Validation management experience including support of large capital projects.
- Excellent verbal and written communication skills, detail-oriented personality, and ability to work and drive change across functions.
- Solid knowledge of global regulations and standards; experience interacting with regulatory health authorities at pre- and post-approval inspection is preferred.
- Experience with Lifecycle management software, experience with Kneat preferred.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Excellent team building, leadership and management skills.
- Excellent listening, communication and interpersonal skills fostering team spirit.
- Consistent delivery of high-quality work at all times.
- Ability to gown and enter clean rooms (i.e. GMP manufacturing spaces).