Associate Director Quality Assurance at Merck · Pune

Associate Director Quality Assurance Location: IND - Maharashtra - Pune (Wework) Job Description The Associate Director, Supplier Quality Management (SQM) will be responsible for all quality aspects related to external suppliers, contract manufacturers, and service providers supporting GMP operations. This role ensures compliance with company policies, procedures, and global regulatory expectations while safeguarding product quality, patient safety, and data integrity. The position will lead supplier quality oversight, manage supplier-related IT systems, and provide leadership to a team of Supplier Quality professionals within Global Quality Shared Services supporting global Sites. As part of the global Quality Assurance organization, the Associate Director SQM will be responsible for: Supplier Quality Oversight: Managing the Approved Supplier List (ASL), ensuring suppliers meet GMP and regulatory requirements. Supplier Change Management: Acting as SME for supplier change notifications, evaluating impact, and ensuring proper approvals. SCAR & CAPA Management: Leading supplier corrective and preventive actions, ensuring timely closure and effectiveness verification. Audits & Inspections: Planning, leading, and supporting supplier audits, regulatory inspections, and follow-up actions. SQMS IT Systems: Overseeing Supplier Quality Management Systems (SQMS), ensuring validated status, compliance, and effective use. Global Stakeholder Management: Collaborating with stakeholders across global manufacturing sites, suppliers, and regulatory bodies to align quality expectations and ensure compliance. Risk Management: Implementing risk-based approaches for supplier qualification, monitoring, and escalation of compliance risks. People Management: Leading, coaching, and developing a team of Supplier Quality professionals to ensure operational excellence. Continuous Improvement: Driving innovation, efficiency, and GMP awareness in supplier quality processes. Key Responsibilities Ensure suppliers are qualified, monitored, and maintained in compliance with GMP and global regulatory expectations. Lead supplier audits and manage audit findings, ensuring corrective actions are implemented effectively. Serve as SME for supplier change management, ensuring changes are assessed for impact on product quality and compliance. Manage SCARs and CAPAs with suppliers, ensuring timely resolution and effectiveness checks. Oversee SQMS IT systems, ensuring compliance with validation, change control, and data integrity requirements. Maintain and update the Approved Supplier List (ASL) in alignment with business and regulatory needs. Provide leadership, coaching, and performance management for Supplier Quality team members. Collaborate with global manufacturing sites to ensure consistent supplier quality practices across regions. Represent Supplier Quality in cross-functional and global meetings, driving resolution of supplier-related compliance issues. Support regulatory inspections and audits related to supplier quality management worldwide. Promote a culture of continuous improvement and GMP compliance across supplier quality processes. Qualifications Bachelor’s degree in Science, Engineering, Information Technology, or Business (Advanced Degree preferred). Minimum 12 years of experience in regulated pharmaceutical manufacturing or supplier quality management, with at least 5 years in a leadership role. Strong understanding of FDA, EU, ICH, and other global regulatory requirements, with emphasis on supplier quality, GMP, and data integrity. Hands-on experience with supplier quality systems, supplier audits, and supplier change management across multiple global sites. Demonstrated expertise in SCAR, CAPA, and risk management processes. Familiarity with SQMS IT systems and computerized system validation. Excellent leadership, communication, and stakeholder management skills, with proven ability to manage global stakeholders. Professional certifications (Six Sigma, PMP, Quality Auditor) preferred. Multi-lingual capabilities and experience in leading regulatory inspection discussions are advantageous. Required Skills: Adaptability, Change Management, Cross-Cultural Awareness, Cross-Functional Teamwork, GMP Training, Good Distribution Practice (GDP), Inspection Readiness, Manufacturing Quality Control, Quality Auditing, Quality Management Standards, Quality Metrics, Quality Systems Compliance, Regulatory Compliance, Risk Management Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 06/5/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.