Associate Director, Quality Assurance

Merck•North Wales, PA

14h•$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 regulatory expectations. The role owns a specific area of complaint management and serves as a subject matter expert on complaint receipt and handling, global complaint trending and reporting, and Adverse Event Quality Investigation reporting for medical devices and combination products. The Associate Director maintains awareness of evolving industry and regulatory trends and supports strong links with other company divisions that own related processes, including adverse events, counterfeits, complaint intake, and device and technical teams. The role oversees complaint management activities and partners with Global Safety, Manufacturing division sites, and external business partners to ensure investigations and health authority reporting are completed promptly and that issues are addressed. It provides expertise on Quality Manual Chapter 8, helps keep related documentation aligned with current regulatory expectations, and contributes to policy and procedure development or revision. The Associate Director also supports regulatory inspections and serves as a liaison among Manufacturing sites, Device Technology, Global Safety, and Global Security. The position independently responds to internal and external partners and regulatory authorities on Adverse Event Quality and Product Quality Complaint issues, including explaining company processes. It leads or participates in cross-functional teams developing processes and database applications for managing and signaling complaints and potential quality-related adverse events, and recommends process improvements to leadership. The role identifies and mitigates regulatory risks, resolves technical and operational problems, supports consistent processes across divisions and external partners, and promotes appropriate use of technology, automation, and artificial intelligence. It may provide developmental feedback, coaching, or mentoring to team members, aligns staff activities with department objectives, and consults with 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 these fields and at least 5 years of related experience; or a Ph.D. in these fields and at least 3 years of related experience.
Relevant experience in 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 with 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 simultaneous projects or tasks with competing priorities and manage time and individual 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 regulatory requirements, with sound risk management in complex and evolving environments.
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 processes for receipt and handling of product quality complaints, global complaint trending and reporting, and Adverse Event Quality Investigation reporting.
Serve as a subject matter expert and work with Global Safety, Manufacturing division sites, and external business partners to ensure investigations and health authority reporting are timely and issues are addressed.
Provide subject matter expertise for Quality Manual Chapter 8 and ensure chapter documentation reflects current regulatory expectations.
Contribute to developing and revising policies and procedures.
Provide regulatory inspection support to Manufacturing division sites for Product Quality Complaints.
Act as a liaison between Manufacturing sites and Device Technology on device/design issues, Global Safety on pharmacovigilance, and Global Security on counterfeit management.
Respond independently to internal and external partner and regulatory authority requests regarding Adverse Event Quality or Product Quality Complaint issues, and explain company processes to authorities.
Lead or participate in cross-functional teams that develop business processes and database applications to manage and signal Product Quality Complaints and potential Adverse Event Quality issues.
Prepare recommendations to leadership for process enhancements aligned with regulatory expectations.
Identify improvement opportunities and 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 Quality Management System.
Identify and resolve technical and operational problems in collaboration with peers.
Improve and streamline complaint management processes, including consistent use of technology, automation, and artificial intelligence where applicable.
Provide developmental feedback, coaching, or mentoring to team members when appropriate.
Align staff activities with department objectives and consult management on decisions as needed.