Senior QA Manager/Qualified Person

Senior QA Manager/Qualified Person

Amicus Therapeutics

Dublin, Ireland

Position Summary

The Senior QA Manager / Qualified Person will be responsible for robust QA oversight of small molecule, large molecule (biologics), packaging/labelling processes associated with Amicus commercial finished products, contract manufactured. Specifically, this position will be responsible for the Quality Oversight and batch certification of Amicus Commercial finished product within the framework of the Amicus Manufacturing and Importation Authorisation (MIA) and the associated duties of the Qualified Person as required by EU Directive 2001/83/EC.

Roles and Responsibilities

Essential Responsibilities

• Ensures that each commercial batch has been manufactured, tested and checked in compliance with laws in force in the Member State where batch certification takes place, following the requirements of the relevant Amicus marketing authorization (MA) and confirming compliance with Eudralex (cGMP’s) Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human Use and Annex 16: Certification by a Qualified Person and Batch Release.
• Fulfils the ethical, professional, and legal duties of the Qualified Person as outlined by EU Directive 2001/83/EC.
• Acquires and maintains detailed knowledge for all GMP manufacturing steps for which the QP undertakes responsibility as part of the batch certification process.
• Confirms the entire supply chain and robustness of associated pharmaceutical quality systems of the finished product lifecycle up to the stage of final batch certification, including the manufacturing and testing sites of all materials and packaging components for finished product and any other materials deemed critical through auditing and risk assessment of the manufacturing processes.
• Confirm all sites of manufacture, analysis and certification are compliant with the terms of the MA for the intended market, with all manufacturing activities and testing activities consistent with those described in the MA.
• Responsible for confirming all audits of sites involved in the manufacture and the testing of the medicinal products including the manufacture of the active substance have been completed and that the audit reports are available prior to batch certification.
• Confirm regulatory post-marketing commitments relating to manufacture or testing of the product have been addressed. Ensures the impact of any change to product manufacturing or testing has been evaluated and any additional checks and tests are complete.
• Confirm the required Quality Technical Agreements are in place across the Supply Chain for the product in place and effective prior to batch certification.
• Confirm the importation of active substances used in the manufacture of medicinal products for human use should comply with the requirements of Article 46(b) of Directive 2001/83/EC, as amended.
• Support preparation for HPRA and other regulatory audits.
• Review relevant modifications of the Amicus Quality Management System (QMS), including new and updated current Good Manufacturing Practices (GDP/cGMP) procedures, forms, and documentation in accordance with HPRA/FDA standards and requirements.
• Participate in joint Quality Review meetings minimally on an annual basis to review mutually agreed key performance indicators.
• Advise on QMS updates, quality agreement updates and license variations required.
• Cooperate in the exchange of information and assistance, as reasonably necessary to effectively respond to inquiries by regulatory authorities regarding the Product(s).
• Review responses to regulatory audit findings (related to the MIA) from the other Parties.
• Maintain a Continuous Professional Development plan, maintain awareness of current Regulations & Guidelines, Legal Requirements and can carry out the services of Qualified Person as stated under EU/HPRA Directive/Regulations or Guidelines. Maintain knowledge and training related to GMP up to date.
• The QP/Quality Professional shall make himself available by phone, e-mail as required in addition to the monthly time agreed on an urgent basis to assist the Company for the duration of this assignment.
• Mutually agree notification to the competent authorities of any product identified as or suspected to be falsified.
• Notify key internal and external stakeholders, within one (1) business day if any problems are discovered that may affect Product batches already shipped to assure that regulatory reporting guidelines may be met.
• Participate in and be aware of any proposed recall, product withdrawal or field action related to Amicus Commercial Finished Product.
• Carry out additional duties associated the role as delegated by Assoc. Director – External Quality Lead (Finished Product Release).

Requirements

Educational Requirements

• The candidate will have attained an academic qualification at least equivalent to a level 8 primary course in a scientific discipline and has successfully completed a recognized post-graduate course in Ireland that satisfies the educational requirements as defined in the EU Regulation 2019/6 and the EU Directive 2001/83/EC, for example Masters in Pharmaceutical Science / Qualified Person.

Professional Work Experience Requirements

• Relevant pharmaceutical experience in compliance with Article 51 of Directive 2001/83/EC, and fulfil the conditions required to act in the capacity of Qualified Person.
• Experience as a named QP for a licensed facility.
• Sterile manufacturing and/or biotech experience required.
• Application of cGMP to manufacturing and testing of API and Drug product manufacture.
• Excellent technical and compliance-based writing skills.
• Managerial or Supervisory experience required.
• Extensive regulatory inspection experience leading a function or group.
• Experience in supporting both regulatory agency inspections and internal GMP audits.
• Demonstrated stakeholder management and escalation experience.

Other Skills/Attributes

• A passion for helping patients with rare diseases and demonstrated alignment with Amicus Mission Focus Behaviors.
• Sound judgment and decision-making, demonstrating ability to analyze and solve problems.
• Experience in working in cross-cultural Quality teams.
• Autonomy, self-motivation, and efficiency, with an appropriate sense of urgency in a fast-paced and dynamic environment.
• Strong verbal and written skills with ability to explain complex, challenging issues in a clear manner to all levels of the organization, especially senior management.
• Strong interpersonal skills, including diplomacy and flexibility, and the ability to engage and influence effectively with key stakeholders across multiple geographies.
• Performing other duties related to the position when required by management.
• Regulatory Affairs experience preferred.
• EU GMP recognized Audit certification preferred.
• Lean Six Sigma certifications preferred.

Travel

• Requires travel domestically and internationally up to 20%.

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