Associate Director, Quality Assurance

Merck; New Jersey; On-site; USD 170,000 - 210,000; Full time

Job summary

Merck in New Jersey is seeking an Associate Director to guide the manufacturing quality complaint management for MDCP regulatory expectations worldwide. You will serve as SME for complaint handling, trending, and health authority reporting with Global Safety and site teams.

You will lead cross-functional initiatives, align with Quality Manual Chapter 8, support regulatory inspections, and mentor team members while driving process improvements through technology and data analytics.

Qualifications

• Bachelor's degree in Science or Engineering with 7+ years related experience, or Master's with 5+ years, or PhD with 3 years.
• Experience in Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical products.
• Strong leadership and ability to manage multiple projects with competing priorities.
• Excellent problem-solving skills based on data, science, and regulatory understanding.

Responsibilities

• Oversee receipt and handling of product quality complaints and adverse event reporting.
• Coordinate investigations with Global Safety, manufacturing sites, and external partners.
• Provide SME input to Quality Manual Chapter 8 and keep documentation current.
• Support regulatory inspections related to product quality complaints.
• Lead cross-functional teams to improve complaint management processes.

Skills

Regulatory knowledge

Quality management

Cross-functional leadership

Problem solving

Communication skills

Education

Bachelor in Science or Engineering

Master's in Science or Engineering

PhD in Science or Engineering

Job description

The Associate Director is responsible for providing guidance to assure our Manufacturing division product quality complaint management processes are in compliance with worldwide medical device and combination product (MDCP) regulatory expectations. Responsible for a specific area of quality complaint management and serves as the subject matter expert; receipt and handling of product quality complaints, trending and reporting of global product quality complaint and/or Adverse Event Quality Investigation reporting for MDCPs. Maintains awareness of evolving industry and regulatory trends associated with complaint management. Assures strong linkages with other our Company divisions that are the business owners for associated processes e.g. adverse events, counterfeits, complaint intake, device/technical teams.

Primary activities include, but are not limited to:

Maintain oversight of the complaint management process associated with receipt and handling of product quality complaints, trending and reporting of global product quality complaint and/or Adverse Event Quality Investigation reporting. Serve as the subject matter expert working with Global Safety, our Manufacturing division sites and External Business Partners to assure investigations and health authority reporting are completed in a timely manner and address any issues resulting from the investigations.

Provides subject matter expertise to Quality Manual Chapter 8 and ensures chapter documentation is consistent with current regulatory expectations. Contributes to developing/revising policy and procedures.

Provides regulatory inspection support to our Manufacturing division Sites as it relates to Product Quality Complaints and serves as the linkage between our Manufacturing division sites and Device Technology for device/design issues, between our Manufacturing division sites and Global Safety for pharmacovigilance, and between our Manufacturing division sites and Global Security for counterfeit management.

Independently supports requests from internal and external partners as well and regulatory authorities regarding Adverse Event Quality or Product Quality Complaint issues. Directly works with the regulatory authorities to address issues and explain our Company processes.

Leads/participates on cross-functional teams developing business processes and database applications that support the management/signaling of PQCs and/or potential AE Quality issues. Prepares recommendations to leadership to enhance processes assuring they are aligned with regulatory expectations. Continuously identifies opportunities for improvements to assure potential regulatory risks are mitigated.

Analyzes issues from different points of view and look at multiple ways to define problems as they work across our Research & Development division, our Manufacturing division and Human Health. Additionally, as the position works with external partners who might have different practices then our Company the position must work to resolve issues to assure alignment with our Company's QMS.

Identifies and resolves technical and operational problems, collaborating with peers to solve problems. Identifies continuous improvement opportunities to streamline the complaint management process, and develop consistent processes including the use of technology, automation, and artificial intelligence where applicable.

Provides developmental feedback, coaching, and/or mentoring to other team members when necessary; in a positive and productive manner, using feedback to help others improve and succeed.

Aligns staff activities with department objectives.

Consults with management on decisions as needed

Qualifications:

A Bachelor's degree in (Science or Engineering or associated fields) with a minimum of 7 years related experience OR a Master's degree (Science or Engineering or associated fields) and 5 years related experience or a Ph.D. (Science or Engineering or associated fields) and 3 years of related experience

Experience:

7 years relevant experience including Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical products; or related fields.

LEADERSHIP:

Requires established ability to manage and implement multiple projects/tasks simultaneously with competing priorities; managing time and personal/group effort. Requires established ability to identify and implement MPS principles and inclusive behaviors for continuous improvement. Excellent problem-solving skills, based on science, facts, data and understanding of regulatory requirements in complex and evolving environments; must be able to apply sound risk management. Strong demonstrated interpersonal, communication, collaboration and leadership skills; and ability to work in a multi-cultural environment.

Required Skills:

Working knowledge of applicable medical device regulations (21CFR820, EU MDR, ISO 13485:2016), Risk Management experience (ISO 14971:2012). Demonstrate the ability to work ef