Validation Manager – Shire – Cambridge, MA, USA
Primary Role
The individual will be responsible for supervising staff at the Lexington facility. Technical duties include setting validation strategy, adhering to domestic and international GMP regulations, incorporating continuous improvements into validation activities and policies, and participate in regulatory inspections. Leadership duties include developing strategy, leading change and motivating and developing personnel.
Periodic travel may be required for business meetings with contract manufacturers, peers / colleagues, vendors/contractors, and to stay current with professional development opportunities.
Routine local travel to Shire HGT operational sites.
Responsibilities
- Varies, 30-80%:
- Develop, maintain, and deploy drug product validation policies and practices in the following areas:
- Facilities
- Equipment
- Shipping / Cold Chain
- Process
- Cleaning
- Steaming / Autoclave
- Computer Systems
- Plant Automation
- Validation Maintenance
- Validation document control and archival program
- Develop and assess the following Quality System elements for Validation:
- Quality Risk Management program
- CAPAs
- Change Controls
- Deviations
- GMP Investigations
On-going:
- Develop, mentor, and coach staff.
- Identify opportunities for continuous improvements, deploy best practices, pro-actively update validation programs to reflect current regulations and trends.
Varies, 10 – 20%:
- Participate and lead partner audits and regulatory agency inspections for Validation.
- Author and review responses to inspection observations and agency questions.
- Author and review sections of regulatory filings and annual product quality reviews.
Education & Experience Requirements
- Minimum requirements include a Bachelor’s degree in a technical, preferably an engineering or biological science discipline and 8-10 years pharmaceutical and/or biopharmaceutical industry experience. An advanced degree or additional industry certification is a plus.
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