Description:
BMS External Manufacturing is looking to recruit on a permanent Contract Senior Manager, Clinical Supply Quality Assurance, reporting to Director, Clinical Supply Chain, QP.
Key Duties And Responsibilities
- Support start-up activities for Clinical Supply Dublin, may include but not limited to:
- Managing the CSCQ-QA Team to support release of materials in line with business quality and CSC expectations.
- Manage work load and prioritization of tasks such as but not limited to Dossier preparation
- Quality support for QMS updates,
- Quality support for TQA maintenance,
- Quality support for Incident reports,
- Use date updates,
- Preparation of PSFs and approval of supply chain flow maps
- Other operational tasks of the CSCQ Quality Team
- Lead, encourage and motivate the CSCQ QA team
- Establish and maintain group metrics with a view to continuous improvement
- Review and approval of CSCQ QMS records and procedures
- Support preparation and approval of training materials
- Support review and approval of Quality Agreements
- Ensure Knowledge transfer from current release site
- Support Manufacturers Authorisation/Warehouse and Distribution Authorisation submissions
- Support sustaining operations, may include but not limited to:
- Support for Health Authority GCP/GDP inspections and audits across the supply chain
- Advise stakeholders on quality issue management and process enhancement/compliance - ensuring consistent quality standards and fostering strong working relationships
- Incorporate global regulatory trends and changes into Supply Chain Quality
- Site master file maintenance
- Manufacturers Authorisation update and maintenance
- Review and approve procedural documents
- Participate in multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline
- Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level
- Proactively identify risk areas
- Provide input in the global audit plans based on identified signals/trends/risks/gaps
- Support OPEX programs and champion continuous quality improvement initiatives
Qualifications, Knowledge And Skills Required
- A degree in science, engineering or related discipline is essential along with a number of years’ experience in a role within the biopharmaceutical/pharmaceutical industry
- Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance
- Proven track record of building/ maintaining high-performance teams/organizations and influencing/ motivating global teams to achieve results-delivering on business and program goals
- Proven leadership / influence management skills with ability to foster partnerships in the matrix organization across functional/ geographic/ cultural/partner boundaries
- Proven clear communication supporting delivery for the business
- Fosters a culture in which people continually work to improve services, and work processes