Job Requisition: CHC Country Quality Manager
Location: Reading, UK
Reports to: Country Quality Head & Responsible Person UK CHC
Mission and Key Responsibilities:
The CHC Country Quality Manager manages the implementation and maintenance of the CHC UK Affiliate Quality System, ensuring compliance with GxP regulatory requirements, CHC Global Quality standards, and UK Legislation.
This role includes acting as back-up Good Distribution Practice Responsible Person and Responsible Person for Import according to Business Contingency Plans.
Key responsibilities include:
- Design, implement, and improve Quality Processes and ensure their respective implementation in the electronic Document Management System.
- Develop, roll-out training activities and oversee training effectiveness.
- Contribute to the selection and qualification of suppliers and subcontractors.
- Support in the identification and mitigation of Quality risks and define action plans in areas as Quality Events, change management, audits and (self-)inspections.
- Ensure Product Quality is maintained through the management of in-market Product Quality Complaints and the effective management of Quality incidents.
- Contribute to continuous improvement efforts through data analysis and trending.
- Manage activities related to the Falsified Medicine Directive.
- Support with Responsible Person import activities.
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Scope and Role Impact:
- Cross-functional management within the CHC UK Affiliate.
- Key role in ensuring consistent application of Quality requirements.
Required Skills and Experience:
- Educational Qualifications: Candidates must possess a diploma, certificate or other evidence of formal qualifications awarded on completion of a university or other higher education course of study in pharmacy, chemistry, medicine, biology, or a related life science.
- Experience: Candidates should have proven experience in the Good Distribution Practices (GDP) domain within an affiliate setting, demonstrating a thorough understanding of the specific challenges and requirements of this area.
- Knowledge:
- Understanding of GxP, quality risk analysis and management, regulatory requirements.
- Familiarity with EU Good Distribution Practices and the UK Rules and Guidance for Pharmaceutical Distributors 2022.
- Languages:
- Proficiency in English
- Technical/Professional:
- Experience in Quality Systems, Continuous Improvement and Life-cycle Management.
- For the RP-I role, you must be a full member of a professional body with a published code of conduct. Acceptable professional body memberships are:Royal Society of Biology,Royal Pharmaceutical SocietyPharmaceutical or Royal Society of Chemistry
- Soft Skills:
- Excellent communication skills
- Good sense of organization, planning, priority setting and initiative.
- Ability to work in a high paced and constantly changing environment.
- Commit to customers.
- Hands-on experience with MS Excel. Experience with other electronic platforms such as Veeva Vault is a plus.
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