Description
QA Compliance Manager: Quality Systems, Capa, APIs
6 Month contract
Based in Dublin
All day rates considered
Job Purpose
The QA Compliance Manager:
- Manages core Quality systems that support External Manufacturing, Global Device Engineering and the Dublin corporate office
- Develops, establishes and maintains quality assurance programs, policies and procedures.
- Supports Quality Leadership in ensuring compliance to regulatory requirements and company procedures
- Directs and leads the QA Compliance team in for the following activities:
- implementing and maintaining quality system for Specialty Brands externally manufactured products
- maintaining the Medical Device quality management system supporting both device and development activities executed by Global Device Engineering Dublin (GDE) and externally manufactured products
- Overseeing Licenses and Manufacturing Authorisations
- Overseeing Quality management system elements supporting Therakos UK Wholesale Distribution activities
- Support a quality culture at College Park and across Specialty Brands external manufacturing
Principal Responsibilities of the role
- Develop and manage Quality Systems required to support externally manufactured products including but not limited to the following:
- Deviations, Change Control, CAPA
- Annual Product Review
- Quality Management Reviews
- Quality Agreements
- Supplier Qualification & Management
- Internal Audit program
- Material Review Board/Issue escalation
- Product Recall process
- Provide quality data and metrics associated with the performance of the Quality system
- Oversee the training program for external manufacturing and GDE ensuring coverage of GMP, GDP and Medical Device requirements
- Lead and direct Regulatory Inspection execution and associated regulatory responses
- Support the maintenance of licenses held by MPIL/external manufacturing, liaising with relevant regulatory bodies
- Direct quality system integration activities for newly acquired products/companies in line with integration timelines,
- Lead Quality Management Reviews of the Quality Systems
- Drive and implement continuous improvements in all areas of the Quality System
- Monitor, review, and analyse development of new/changing regulatory requirements relating to Quality Systems and ensure communication/implementation of changes as required.
- Provide quality management system support for Therakos UK Wholesale Distribution Authorisation
- Participate in teams to harmonise global policies, process and procedures.
- Escalate any compliance concerns to senior leadership
Requirements/Expectations
Experience/Skills:
- Min B.Sc. or equivalent in Chemistry, Chemical Engineering or related science. Advanced degree preferable.
- Min 10 years' experience in cGMP systems, pharmaceutical manufacturing and testing
- In-depth GDP and GMP experience with sterile manufacturing and/or biotech experience an advantage
- Advanced Quality systems knowledge
- Self-directed with the ability to delegate, execute and prioritize work tasks/projects with an awareness of escalation responsibility as needed
- Excellent interpersonal skills with the ability to influence effective outcomes with colleagues
- Advanced critical problem solving skills
- Demonstrated data driven decision making ability
- Demonstrated advanced organizational and operational agility, able to operate at all levels of the organization and able to shift priorities successfully
- Six Sigma/Lean experience or qualification and advantage
- Strong Communication and interpersonal skills commensurate with the requirements of operating successfully within a global virtual organization
- Comprehensive knowledge of the pharmaceutical industry and its unique business and social responsibilities
- Excellent facilitation and presentation skills
- Ability to work with stakeholders in a global virtual organization
- Ability to manage projects involving multiple functional groups without direct reporting authority
Competencies:
- Strong communication skills, both written and verbal
- Demonstrated leadership abilities
- Demonstrated commitment to excellent customer service
- Conflict resolution skills
- Requires mature judgment in problem solving situations
- Requires negotiation skills to effectively influence others
- Ability to drive continuous quality improvement
Due to the volume of applications, we regret that we can only respond to those meeting our above requirements.