Associate Director, External Quality Lead (Small Molecule)

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.

Position Summary

The External Quality Lead (EQL) Associate Director will be responsible for leading and coaching a team of quality professional(s), and for all Quality Assurance activities in support of Amicus’s External Manufacturing operations for small molecule products. Working in partnership with Technical Operations, Regulatory and other internal partners, the EQL Associate Director is actively engaged in ensuring outsourced manufacturing is performed in compliance with Amicus procedures and standards, and applicable regulations and standards. The EQL Associate Director will also provide the Quality Assurance oversight of Amicus’s strategic initiatives, the development of biologics, small molecule, contract manufacturing, batch disposition, risk assessments, and quality control. This position will support on an as needed basis in the areas of Pharmaceutical Development, Technology Transfer, process scale-ups, manufacturing for new and existing products and Continued Process Verification (CPV) activities.

The EQL Associate Director will work to build and maintain effective relationships with our external partners and ensure the effectiveness of our governance process. The EQL Associate Director will drive performance against agreed performance measures.

Roles and Responsibilities

• Provides oversight of Amicus’s External Manufacturing activities, working in partnership with Technical Operations and Regulatory Affairs to ensure compliance of outsourced activities with Amicus procedures, and Global Regulations and Guidance.

• Leads, coaches, and coordinates the work of quality professionals responsible for the management our External Manufacturing partners.

• Leads, coaches, and coordinates the work of quality professionals responsible for the management of achieving Amicus’s corporate and the Quality organization’s strategic and annual objectives.

• Responsible for product batch disposition and associated activities such as raw material or API disposition as needed.

• Ensures the effective investigation of manufacturing deviations, laboratory investigations, temperature excursions, product complaints in compliance with the requirements of GMP.

• Ensures Inspection Readiness and supports Amicus and our External Partner’s preparations for Regulatory Inspections preparations.

• Activity involved in Amicus’s Governance Processes, including preparation of reports and metrics and KPI’s. Identifying trends and ensure appropriate actions are implemented.

• Ensure effective and compliant Quality Technical Agreements are in place.

• Participates as needed in management and performance reviews with our External Partners.

• Actively engaged in continuous improvement and drives efficiency and process improvement projects within Amicus and in partnership with our External Manufacturing partners.

• Project management and QA representative for new process and system implementations.

• Perform Vendor audits and manage the qualification of external partners and vendors.

• Ensures all work is performed and documented according to approved standard operating procedures, in general compliance with cGMPs and in a timely manner consistent with agreed upon schedules.

• Supports and approves process and analytical validation activities (to include Technology Transfers, Process Scale-ups) and documents as required, including Continued Process Verification activities.

• Supports and approves process and analytical technology transfers and documentation as required.

• Supports regulatory filing activities.

• Identify problems through trend and investigational data and conduct independent or team driven problem-solving using root cause analysis.

• Supports Annual Product Quality Reviews.

Requirements

Educational Requirements

• Minimum of a Bachelor’s Degree in the Sciences (Microbiology, Biology, Chemical Engineering, etc.)

Professional Work Experience Requirements

• Must have 12 years of experience in Biotech manufacturing with an in-depth knowledge of current Good Manufacturing Practices, Quality System regulations, and ISO standards.

• Must have 5 years of experience of successfully leading a customer focused organization to include Quality Assurance or Manufacturing teams in the pharmaceutical manufacturing environment.

• Experience with both process and analytical qualification or validation activities.

• Experience with facility, equipment and process qualification and validation activities.

• Experience with product batch disposition activities.

• Experience in leading and supporting both regulatory agency and internal inspections

• Demonstrable experience in Quality Assurance; preferably with strong experience of managing a quality team.

• Working knowledge of FDA and EMA GMP, and other applicable Global regulations

• Management of Contract Manufactures and Vendors.

• Development, reviewing, and approving cGMP related documents (batch records, SOPs, protocols, reports, etc.).

• Experience in reviewing investigations, evaluating root cause and corrective action plans.

• Leading performance reviews, and developing performance measures, metrics, and reporting KPIs.

Experience and Skills

• A passion for helping patients with rare diseases

• Excellent judgment and decision-making, demonstrating ability to analyze and solve problems.

• Experience in leading cross-cultural Quality teams.

• Autonomy, self-motivation, and efficiency, with an appropriate sense of urgency in a fast-paced and dynamic environment.

• Experience of managing complex projects, leading cross-cultural teams, and budget planning.

• Knowledge of Pharmaceutical Drug Substance and Drug Product Manufacturing and Distribution operations.

• 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.

• Demonstrated ability to serve as a knowledgeable resource to the organization's management team that provides leadership and direction.

• Understanding of Quality by Design (QbD) principles as they relate to biologics and small molecule manufacturing.

Other skills/Attributes

• Demonstrated alignment with Amicus Mission Focus Behaviors

• ASQ CQE/CQA certification preferred

• Lean Six Sigma certifications preferred

Travel

• Requires travel domestically and internationally up to 20%.

We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence.Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.

Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.

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