Associate Director, Quality Assurance

Job DescriptionThe West Point Quality organization ensures our products are manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. The Associate Director, Inspections lead will be a core member of the West Point Quality Assurance Leadership Team and serves as a quality leader accountable for the quality oversight and management of the Quality team overseeing Regulatory Inspections and Health Authority reporting supporting the West Point Manufacturing and Quality Control laboratories. The position will be responsible to ensure site’s compliance with applicable regulations, industry standards and Quality Management Systems. The incumbent will be responsible for developing, implementing and leading a group of compliance professionals through the deployment of compliance programs, monitor compliance efforts and advise site senior management on compliance related matters. The role involves serving as the lead for regulatory agency inspection coordination and collaborating with other departments to address compliance issues. The responsibilities of this role will additionally include sustainment through continuous improvement of the organization at the site.Primary activities include, but are not limited to:Develop and implement comprehensive compliance program for the site to ensure Permanent Inspection Readiness (PIR), which includes Health Authority Reporting and inspection readiness team.Track and Interpret changes in regulations, industry standards and ensure proactive awareness and PIR at the site.Conduct regular compliance risk assessments, identify potential risks and develop strategies to mitigate the risks. Identify and address compliance issues, develop corrective action plans and implement improvements to compliance programsAct as a liaison and/or SME to present operational compliance to Health Authorities and regulatory agencies on relevant topics.Lead a team of professionals who serve as contact for regulatory agencies during inspections, responding to inspectional or regulatory agency inquiries, providing information and addressing compliance concerns.Serve as Manager to the lead for the team coordinating Health Authority reporting, Market action events, and complaint process management for the site.Provide training and guidance to employees on compliance related matters, ensuring a robust PIR at the site.Provide expertise in developing strategies for inspection readiness including working with Regulatory with relevant submissions for new product launchesSkills in engaging and collaborating with various functional teams (e.g., Operations, Technology, Automation, Regulatory, Research).Ability to build relationships and work effectively in a team-oriented environment.Engage and drive continuous improvement initiatives across the site to drive simplification and standardization.Required Experience, Skills, and Knowledge:Applicable experience, strong understanding and knowledge of relevant quality systems expectations in the biotechnology or vaccine industry.Expert knowledge of cGMP relevant to the biotechnology or vaccine industry including knowledge of the local and international GMP regulations.In-depth knowledge of regulatory requirements and guidelines (e.g. 21 CFR part 11, Annex 11).Ability to work independently while fostering collaboration in team settings and matrix organizations to achieve common goals.Highly skilled in listening to diverse perspectives, developing impactful solutions, and advocating for effective positions through influence.Strong working knowledge of Quality Management Systems, and associated business processes.Excellent communication, leadership, technical writing and problem-solving skillsAbility to cultivate positive, transparent, and productive relationships across various stakeholders.A team player with high initiative, demonstrated planning skills, proven performance in problem-solving, team building and staff development.Experience in working with cross functional teams as well as good leadership skills in a matrix organizationExperience in managing cross-functional initiatives or programsMinimum Education Requirements and Experience:Bachelor’s degree (BS) or Master’s degree (MS) with Ten (10) years applied professional work experience in one of the following pharmaceutical work areas: quality assurance, compliance, manufacturing operations, technical operations.Preferred QualificationsExperience leading regulatory inspection readiness and Health Authority inspections in a pharmaceutical, biotech, or vaccine environmentStrong knowledge of quality systems, compliance oversight, and CAPA managementDemonstrated ability to lead cross-functional initiatives in a matrix environmentExperience interacting with regulatory agencies and senior leadershipStrong understanding of health authority reporting, complaint management, and market action processesAbility to interpret complex regulations and translate them into practical site-level actionsProven leadership, coaching, and team development skillsExcellent communication, influence, and relationship-building skillsStrong organizational and problem-solving skills with a continuous improvement mindsetExperience driving simplification, standardization, and process improvement across a site #EBRG's #VetJobsRequired Skills: Change Management, Computer System Validation (CSV), Decision Making, Driving Continuous Improvement, GMP Laboratory, People Leadership, Performance Qualification (PQ), Quality Auditing, Quality Control Documentation, Quality Management Standards, Quality Management Systems (QMS), Quality Risk Management, Regulatory Compliance, Supplier Quality Management, Training and DevelopmentPreferred 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$142,400.00 - $224,100.00This 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:DomesticVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:Not ApplicableShift:1st - DayValid Driving License:NoHazardous Material(s):N/AJob Posting End Date:09/17/2026*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 PointType: Full time