Assoc. Dir, External Quality

Job Description

The Associate Director, Supplier Quality Assurance (SQA) provides strategic oversight of global API suppliers, ensuring compliance with company standards, cGMP, and applicable regulations. The role safeguards product integrity and patient safety across API manufacturing, packaging, testing, and distribution, operating effectively in a virtual, matrixed organization through decisive leadership and strong cross‑functional collaboration.

Success in this role is achieved through deep technical expertise, risk-based guidance, and proactive engagement with suppliers and internal stakeholders. The Associate Director applies advanced knowledge of global regulatory frameworks and evolving compliance standards to deliver hands-on support, practical coaching, and strategic influence. By fostering robust quality systems and audit-ready processes, while leveraging leadership, problem-solving skills, and collaborative partnerships, the position ensures sustainable supplier performance. This includes navigating complex regulatory landscapes, adapting to change, and working seamlessly across functions to maintain compliance and continuous improvement in a globally connected network.

·       Serve as the primary Quality liaison for strategic API suppliers, ensuring sustained compliance with GMP, company standards, global regulations (EU, FDA, others), Annex 1 where applicable, and the company's Quality Manual.

·       Maintain and negotiate Quality Agreements; ensure alignment with Commercial Agreements and update as needed.

·       Assess supplier capability using risk-based tools; plan and lead on-site/remote audits, issue evidence-based reports, and drive effective CAPA with verification of effectiveness.

·       Strengthen supplier Quality Management Systems (change control, deviations, CAPA, OOS/OOT, document control, training, internal audits, management review).

·       Review, approve, and manage supplier change controls; coordinate regulatory impact assessments with cross-functional partners.

·       Lead investigations into deviations, OOS/OOT, microbiological excursions, stability issues, and complaints; ensure robust root-cause analysis, remediation, and required regulatory reporting.

·       Provide oversight for technology transfers and support process validation to ensure compliant, robust product realization.

·       Drive inspection readiness and represent during regulatory interactions and inspections.

·       Monitor supplier performance via KPIs and periodic reviews; identify trends and implement systemic corrective/preventive actions.

·       Collaborate with Technical, Regulatory, Procurement/Supply Chain, and manufacturing sites to ensure alignment, timely issue resolution, and risk management.

·       Proactively escalate critical quality or supply-continuity risks to senior management with clear, actionable recommendations.

·       Coach and mentor supplier and internal teams to build capability and foster a strong quality culture.

Operate effectively in a global, virtual, matrixed environment; travel to supplier sites as required and keep the Director, SQA informed of status, opportunities, and issues.

·       Education: Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering, or a related scientific/engineering field.

·       Experience: 8+ years in GMP-regulated environments (API and/or drug product), with proven responsibility in Quality Assurance/Quality Control and manufacturing/technical operations.

·       Regulatory/GMP expertise: Strong working knowledge of EU, FDA, and relevant global regulations; familiar with ICH guidelines and Annex 1 (where applicable).

·       Quality Systems: Hands-on experience with QMS elements (change control, deviations, CAPA, OOS/OOT investigations, document control, training, internal audits, management review).

·       Technical investigations: Ability to lead root‑cause analysis and remediation for deviations, OOS/OOT, microbiological excursions, stability issues, and complaints.

·       Communication: Demonstrates strong overall communication skills, including fluency in English and the ability to communicate clearly and effectively in both English and Chinese across diverse audiences.

·       Collaboration and leadership: Strong interpersonal, negotiation, and influencing skills; effective working across cultures and in virtual, matrixed organizations.

·       Autonomy: Able to work independently with limited supervision; demonstrates ownership and follow‑through.

·       Travel: Willing and able to travel ~25% domestically and internationally.

·       Certifications: Formal auditor training/certification (e.g., GMP Auditor, ISO 9001/13485); quality certifications (e.g., ASQ CQE/CQA) beneficial.

·       Sterile and biologics experience: Exposure to sterile manufacturing/Annex 1, biologics, vaccines, or combination products.

·       Technology transfer/validation: Experience supporting technology transfers and process validation activities.

·       Regulatory engagement: Direct experience supporting or participating in regulatory inspections (FDA, EMA, PMDA) and inspection readiness.

·       Digital/QMS tools: Proficiency with electronic QMS/LIMS/TrackWise or similar systems; strong Excel and data analysis skills for KPI trending and reporting.

·       Continuous improvement: Demonstrated ability to simplify processes, implement systemic CAPA, and drive sustainable improvements.

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·       Focus on Customers and Patients

·       Make Rapid, Disciplined Decisions

·       Act with Courage and Candor

·       Demonstrate Ethics and Integrity

·       Drive Results

Foster Collaboration