QA Validation Associate Director – Shire Pharmaceuticals Group – Massachusetts, USA
The QA Validation Associate Director is responsible for managing and leading QA validation efforts at Shire and Contract Manufacturing Organizations (CMOs). The role includes managing people, providing quality and technical direction to cross-functional teams, and actively participation in driving and developing strategies for continuous improvement of the engineering/facilities/validation quality systems.
The QA Validation function is primarily responsible for the following activities:
* Ensuring a robust quality system is in place for facility, equipment & lab instruments, engineering, maintenance, supply chain, computerized systems and validation activities which comply with global regulatory requirements, industry best practices and will successfully withstand regulatory inspections by regulatory authorities.
* QA Oversight and support of Product technology transfers, participation in CMC teams
* QA oversight of change control for manufacturing systems – including Facility/equipment projects
* QA Oversight of qualification, computer system validation, cleaning validation, and process validation
* The scope of responsibility encompasses the product life cycle for existing commercial pharmaceutical and biopharmaceutical products as well as emerging products and platforms.
The position will independently interact with all levels of internal customers within the QA, Validation, Facilities, Engineering, Manufacturing, Materials Management, QC, and Regulatory Affairs functions.
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 operational sites and offices.
Responsibilities
Varies, 30-80% Develop, maintain, and deploy 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
* Analytical Instruments
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.
