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Director, Commercial Affiliate QA GMP GDP and Qualified Person

Website Achieva Group Limited

An excellent permanent opportunity has arisen to join a leading pharmaceutical company as a Director, Commercial Affiliate QA GMP GDP and Qualified Person.

Job Responsibilities
Director, Commercial Affiliate QA(GMP/GDP) and Qualified Person is a strategic role to achieve enhanced Quality and Regulatory (GMP/GDP) Compliance within EU affiliates by developing and implementing a standardized QMS across EU affiliates aligned with HQ QA requirements and ensuring adherence to GMP and GDP requirements for the products within the Supply Chain. Experience as a Qualified Person, preferably in Germany, and PV QA experience is a plus.

• Develop, maintain and drive compliance of the Affiliate Quality Management Systems against the company’s Quality Policies, industry standards and local GMP/GDP related regulatory requirements
• Manage Affiliate documentation and training records within Idorsia Quality System, in collaboration with HQ QA and affiliate. Review and approve local (GxP related) standard documentation and develop local Quality related procedures as appropriate, in accordance with HQ QA principles and processes.
• Ensure the provision of appropriate quality related training for regulated activities in affiliates and monitor training compliance.
• Ensure appropriate and timely management of non-conformances related to relevant GxP (GMP/GDP): deviations, change controls, internal and external CAPAs, Quality Events.
• Monitor quality system performance versus local quality relevant GxP and Idorsia requirements via use of pertinent quality and compliance metrics and goals, in alignment with HQ QA guidance and principles. As needed, collaborate with HQ QA for reflecting the affiliate indicators specifics in the HQ quality performance management review.
• In charge of affiliate Quality Management Review in collaboration with Local Responsible Person for medicinal product distribution/wholesale, if applicable. Escalate as needed to HQ QA the highlights of the affiliate’s review.
• Notify and engage HQ QA and other affected stakeholders with any substantial concerns regarding product quality, safety and/or compliance, as per the escalation procedures.
• Lead / support in collaboration with HQ QA external audit and inspection and report and track these and any other relevant field action activity into the relevant quality systems. Ensure that the affiliate quality system is in constant state of readiness for planned and ad hoc audits or inspections. This activity should be performed as appropriate in collaboration with EU QPPV/National QPPV/Affiliate Safety Manager, the Local Responsible Person and any other relevant stakeholders.

Qualifications and Experience

• Graduate Degree in Pharmacy, or other scientific or health related fields (BSc at minimum); additional knowledge in Quality Assurance/Compliance and Auditing
• Fluent in English and German both written and spoken required; intermediate knowledge of French is a plus
• Experience: at least 5 years of experience in pharmaceutical industry in QA and PV field including GDP for commercial products and GMP
• Experience in regulatory inspection management, interactions with health authorities
• Experience as a QP
• Well-organized, able to switch priorities quickly and manage multiple activities and timelines
• Excellent communication skills (orally and in writing)
• Investigation, problem solving, risk analysis & management, negotiation and influencing skills
• Ability to work independently as well as in a team environment
• Comprehensive knowledge of GMP/GDP requirements and PV regulations including product complaint and recall management

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