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Commercial Affiliate QA Manager (GMP/GDP)

Website Achieva Group Limited

An excellent opportunity has arisen to join a leading pharmaceutical company as a Commercial Affiliate QA Manager (GMP/GDP).

The Commercial Affiliate QA Manager (GMP/GDP) 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 clients 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 clients 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 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.
• Ensure local PV related vendors/external partners in the affiliates are qualified (Approved Supplier List) and are appropriately monitored/audited against relevant company and local standards.
• Based on local requirement, conduct as appropriate GxP related self-inspections that are applicable to the affiliate activities, respectively perform internal audits/self-inspections of other affiliates.
• In interaction with the Local responsible person and HQ QA, process Product Quality Complaints through relevant electronic systems, escalate critical product issues and support execution of (mock) recalls and other (mock) field actions in a timely manner.
• Evaluate changes and proposed changes to country specific laws and regulations related to quality (GMP/GDP). Keeping Affiliate Management and HQ QA informed about significant changes and maintaining an updated record of applicable country specific laws, regulations, requirements and regulatory procedures related to quality (GMP/GDP). Support the ASM to conduct impact assessment for new or updated PV regulations.

Requirements:
• 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 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 is a plus
• 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
• Able to manage and resolve technical and tactical issues according to departmental/company procedures and regulations.
• Is strategic in compliance views and is able to provide coaching and guidance to project teams in developing and implementing new quality assurance procedures. Has a quality mindset.
• Able to establish collaborative partnerships with internal and external stakeholders and colleagues, and apply diplomatic skills in resolving difficult situations.
• Identifies and proposes balanced management of quality and compliance risks with business needs.
• Proficient in the use of Microsoft Office applications

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