Associate Director, Quality Assurance

MSD • North Wales, PA

1d • $142,400 - $224,100 • Hybrid

About The Position

The Associate Director provides guidance to ensure the Manufacturing division’s product quality complaint management processes comply with worldwide medical device and combination product (MDCP) regulatory expectations. The role is the subject matter expert for a specific area of complaint management, including complaint receipt and handling, global complaint trending and reporting, and Adverse Event Quality Investigation reporting for MDCPs. The Associate Director maintains awareness of evolving industry and regulatory trends and ensures strong connections with business owners of related processes, including adverse events, counterfeits, complaint intake, and device and technical teams.

The position oversees complaint management and works with Global Safety, Manufacturing sites, and External Business Partners to ensure investigations and health authority reporting are timely and issues arising from investigations are addressed. It provides expertise for Quality Manual Chapter 8, contributes to policy and procedure development and revision, supports regulatory inspections, and helps coordinate responses to internal and external partners and regulatory authorities. The role also leads or participates in cross-functional process and database development, recommends process improvements, resolves technical and operational issues, and supports team development and alignment with department objectives.

The role is based in Rahway, New Jersey, with a hybrid work arrangement. The stated travel requirement is 10%, and the shift is first shift (day).

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 5 years of related experience; or a Ph.D. in those fields and 3 years of related experience.
• The qualifications also state 7 years of relevant experience in Regulatory CMC, Quality, development, manufacturing, testing, 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 with ISO 14971:2012.
• Ability to manage and implement multiple projects or tasks simultaneously with competing priorities and manage time and personal or group effort.
• Ability to identify and implement MPS principles and inclusive behaviors for continuous improvement.
• Strong problem-solving skills grounded in science, facts, data, and understanding of regulatory requirements in complex and evolving environments, including sound risk management.
• Demonstrated interpersonal, communication, collaboration, and leadership skills, and ability to work in a multicultural environment.
• Ability to work effectively in teams and independently within a cross-functional framework, including detailed technical writing and review.
• Creative thinking, resourcefulness, and networking skills to coordinate projects or solve problems.
• Excellent interpersonal relationship skills and 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.
• Required skills listed: adaptability, complaints investigation, creative thinking, cross-functional teamwork, medical device regulations, problem resolution, and working independently.

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 processes for receiving and handling product quality complaints, trending and reporting global complaints, and reporting Adverse Event Quality Investigations.
• Serve as the subject matter expert and work with Global Safety, Manufacturing division sites, and External Business Partners to ensure timely investigations and health authority reporting and address investigation-related issues.
• Provide subject matter expertise for Quality Manual Chapter 8 and ensure its documentation aligns with current regulatory expectations.
• Contribute to the development and revision of policies and procedures.
• Support regulatory inspections at Manufacturing division sites relating to Product Quality Complaints.
• Link Manufacturing sites with Device Technology on device and design issues, Global Safety on pharmacovigilance, and Global Security on counterfeit management.
• Independently support internal and external partner and regulatory authority requests concerning 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 for managing and signaling product quality complaints and potential Adverse Event Quality issues.
• Prepare recommendations for leadership to improve processes and align them with regulatory expectations; identify opportunities to mitigate potential regulatory risks.
• Analyze issues from multiple perspectives across Research & Development, Manufacturing, and Human Health, and resolve differences with external partners to align practices with the company’s QMS.
• Identify and resolve technical and operational problems in collaboration with peers.
• Identify continuous improvement opportunities, streamline complaint management, and develop consistent processes using technology, automation, and artificial intelligence where applicable.
• Provide developmental feedback, coaching, and mentoring to team members when needed.
• Align staff activities with department objectives.
• Consult with management on decisions as needed.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Annual bonus and long-term incentive, if applicable.

What This Job Offers

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