Associate Director, Internal Auditing- Hybrid

Our Research Laboratory Quality Assurance mission is to safeguard the rights and well-being of patients, the welfare of animals, and comply with applicable global regulatory requirements through sound processes and procedures. We provide independent assurance that delivers high-quality data and clinical supplies. The Compliance and Quality Management Systems (CQMS) organization, part of the larger Global Development Quality (GDQ) within Research Laboratory Quality Assurance, is accountable for critical activities in compliance, quality systems, regulatory intelligence, and the Quality Management System (QMS).

About the role

The Associate Director of Internal Auditing reports to the Audit Management and Regulatory Intelligence Lead in Development Quality. This role is responsible for developing, implementing, and maintaining robust processes and procedures to ensure continuous compliance of investigational medicinal products with cGMPs and relevant international regulations (e.g., USA, EU). The Associate Director will lead and support activities including internal audits, GMP readiness, Health Authority inspections, Quality Risk Management, and general compliance initiatives.

Responsibilities

• Independently lead and support comprehensive internal audits and assessments of GMP facilities and business applications/systems supporting clinical supplies manufacture, testing, storage, and distribution to ensure compliance with relevant regulations, policies, and procedures.
• Issue reports summarizing findings and track resulting actions to satisfactory closure to maintain appropriate risk posture for the site.
• Develop and maintain metrics and key performance indicators to measure trends and improve quality performance. Raise unresolved issues or trends to relevant management.
• Present outcomes to management and governing Quality Councils when applicable.
• Maintain an expert level of knowledge about GMP requirements and industry trends as described in applicable worldwide regulations. Provide guidance and interpretation of GMP, regulatory, and compliance standards.
• Develop and harmonize procedures and processes that promote, facilitate, and ensure compliance with worldwide regulations and industry standards in support of the company’s objectives.
• Lead and support GMP readiness activities for new manufacturing facilities, laboratories, and support areas.
• Support the preparation and execution of Health Authority Inspections and company audits as needed.
• Promote a culture of quality and operational excellence. Proactively identify, develop, and implement opportunities for improvement and work across multiple organizations to influence and implement solutions.
• Represent Development Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing Quality guidance.
• Support the Risk Management program as needed by participating in risk identification and remediation for risk assessments.

Requirements

• Bachelor's Degree in an appropriate Science (chemistry, biology, biochemistry, microbiology), IT, or Engineering discipline. Advanced degree preferred.
• Minimum 8 years of experience in the pharmaceutical, biopharma/biologics, or related industry.
• Experience in multiple functional areas such as quality assurance, computer system validation, quality control, manufacturing, research and development, supply chain, facilities, and engineering.
• Extensive knowledge of FDA and EU GMP regulations as well as ICH guidelines.
• Demonstrated knowledge and direct experience with the application of System Document Lifecycle requirements in GMP areas.
• Experience leading audits.
• Ability to travel between sites (e.g., West Point, PA and Rahway, NJ).
• Strong leadership skills and the ability to lead cross-functional teams.
• Experience using electronic quality systems to monitor, report, and track quality tasks and key performance indicators.
• Excellent attention to detail.
• Proficient with digital tools and computer applications; competency in MS PowerPoint, Excel, and Word.
• Excellent verbal and written communication and presentation skills.
• Ability to independently prioritize and manage multiple projects and tasks simultaneously, ensuring timely delivery and meeting business objectives.

Preferred Qualifications

• Familiarity with R&D or clinical supply areas and processes.
• Experience with computer system applications (e.g., Delta-V and/or PAS-X, SAP, electronic laboratory notebooks, Veeva, LIMS, Empower).
• Experience using AI tools and applications.
• Demonstrated experience using Quality Risk Management tools.
• Experience leading and/or supporting US and EU health authority inspections.
• Superior collaboration and teamwork skills.
• Understanding of lean sigma principles and tools.
• Sterile manufacturing experience and knowledge of US and EU aseptic processing guidelines.

Skills

• Computer System Validation (CSV)
• GMP Compliance
• Medical Device Regulations
• Quality Systems Compliance
• Regulatory Compliance

Pay

The salary range for this role is $129,000.00 - $203,100.00. An employee’s position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits including:

• Medical, dental, vision healthcare, and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Schedule

• Travel Requirements: 25%
• Flexible Work Arrangements: Hybrid
• Shift: 1st - Day