Associate Director, Internal Auditing- Hybrid

Job DescriptionThe mission of our company’s Research Laboratory Quality Assurance is to: safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies.The Compliance and Quality Management Systems (CQMS) organization is part of the larger Global Development Quality (GDQ) organization within our company's Research Laboratory Quality Assurance and is accountable for the execution of critical activities in the areas of compliance, quality systems, regulatory intelligence, and the Quality Management System (QMS).The Associate Director of Internal Auditing position reports to the Audit Management and Reg Intel Lead in Development Quality. The Associate Director is responsible for developing, implementing and maintaining robust processes and procedures used 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 that include, but are not limited to internal audits, GMP readiness, Health Authority inspections, Quality Risk Management and general compliance initiatives.The primary responsibilities of this role include, but are not limited to: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 to 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 our 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 the risk identification and remediation for risk assessments.Education:Required: Bachelor's Degree in appropriate Science (chemistry, biology, biochemistry, microbiology), IT or Engineering disciplinePreferred: Advanced degreeRequired: 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: 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 experienced 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.#eligibleforERPRequired Skills: Computer System Validation (CSV), GMP Compliance, Medical Device Regulations, Quality Systems Compliance, Regulatory CompliancePreferred Skills: Current Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your RightsEEOC GINA Supplement​We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.Learn more about your rights, including under California, Colorado and other US State ActsThe salary range for this role is$129,000.00 - $203,100.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. 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.We offer a comprehensive package of benefits. Available benefits include 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 .You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:25%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:YesHazardous Material(s):N/AJob Posting End Date:08/10/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. SummaryLocation: USA - Pennsylvania - West Point; USA - New Jersey - RahwayType: Full time