Associate Director, Quality Assurance

MSD • Rahway, NJ

3d • Hybrid

About The Position

The Associate Director provides guidance and subject matter expertise to help ensure the Manufacturing division’s product quality complaint management processes comply with worldwide medical device and combination product regulatory expectations. The role oversees complaint receipt and handling, global product quality complaint trending and reporting, and Adverse Event Quality Investigation reporting for medical devices and combination products. It maintains awareness of evolving industry and regulatory expectations and coordinates with other company divisions that own associated processes, including adverse events, counterfeit management, complaint intake, and device and technical matters.

The position supports Manufacturing division sites and external business partners in completing investigations and health authority reporting on time, addressing investigation issues, and supporting regulatory inspections. It provides expertise for Quality Manual Chapter 8, helps keep related documentation aligned with current regulatory expectations, and contributes to policy and procedure development. The Associate Director serves as a connection among Manufacturing sites, Device Technology, Global Safety, and Global Security, and works directly with regulatory authorities and internal and external partners on product quality complaint and Adverse Event Quality matters.

The role also leads or participates in cross-functional work to develop business processes and database applications for managing and signaling product quality complaints and potential Adverse Event Quality issues. It recommends process enhancements, identifies and mitigates regulatory risks, resolves technical and operational problems, and pursues continuous improvement, including appropriate use of technology, automation, and artificial intelligence. The position works across Research & Development, Manufacturing, and Human Health, including with external partners whose practices may differ, to resolve issues and align processes with the company’s quality management system. It may provide developmental feedback, coaching, or mentoring, align staff activities with department objectives, and consult management on decisions as needed.

Requirements

• Bachelor’s degree in Science, Engineering, or an associated field and at least 7 years of related experience; or a Master’s degree in those fields and at least 5 years of related experience; or a Ph.D. in those fields and at least 3 years of related experience.
• At least 7 years of relevant experience, including Regulatory CMC, Quality, development, manufacturing, testing, or licensure of pharmaceutical products, or related fields.
• Working knowledge of applicable medical device regulations, including 21 CFR 820, EU MDR, and ISO 13485:2016.
• Risk management experience, including ISO 14971:2012.
• Ability to work effectively in teams and independently within a cross-functional framework.
• Ability to perform detailed technical writing and review.
• Ability to manage and implement multiple projects or tasks simultaneously with competing priorities, managing time and personal or group effort.
• Ability to identify and implement MPS principles and inclusive behaviors for continuous improvement.
• Excellent problem-solving skills grounded in science, facts, data, and regulatory requirements in complex and evolving environments, with sound risk management.
• Strong interpersonal, communication, collaboration, and leadership skills, including the ability to work in a multicultural environment.
• Creative thinking, resourcefulness, and networking skills to coordinate projects and solve problems.
• Flexibility to adapt to a fast-paced environment with changing priorities.
• Ability to work in a matrix organization and communicate effectively in writing and orally.

Nice To Haves

• Experience in the complaint-handling investigation process.
• Understanding of combination product regulations, including 21 CFR Part 4 and post-market safety reporting requirements.

Responsibilities

• Oversee complaint management for receipt and handling of product quality complaints, trending, and global product quality complaint and/or Adverse Event Quality Investigation reporting.
• Serve as subject matter expert and work with Global Safety, Manufacturing division sites, and external business partners to support timely investigations and health authority reporting and address investigation issues.
• Provide subject matter expertise for Quality Manual Chapter 8 and ensure its documentation reflects current regulatory expectations.
• Contribute to developing and revising policies and procedures.
• Support regulatory inspections at Manufacturing division sites relating to Product Quality Complaints.
• Link Manufacturing sites with Device Technology on device/design issues, Global Safety on pharmacovigilance, and Global Security on counterfeit management.
• Independently respond to internal and external partner and regulatory authority requests regarding Adverse Event Quality or Product Quality Complaint issues.
• Work directly with regulatory authorities to address issues and explain company processes.
• Lead or participate in cross-functional teams developing business processes and database applications to manage or signal product quality complaints and potential Adverse Event Quality issues.
• Prepare recommendations to leadership for process improvements aligned with regulatory expectations.
• Identify opportunities to mitigate potential regulatory risks and improve and streamline complaint management, including consistent use of technology, automation, and artificial intelligence where applicable.
• Analyze and resolve complex issues across Research & Development, Manufacturing, Human Health, and external partners, aligning differing practices with the company’s quality management system.
• Identify and resolve technical and operational problems in collaboration with peers.
• Provide developmental feedback, coaching, and/or mentoring to team members when necessary.
• Align staff activities with department objectives and consult with management on decisions as needed.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays.
• Vacation.
• Compassionate days.
• Sick days.
• Eligible for annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Director