PThe Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients (API), biologics, vaccine drug substances and finished products. As Director, you will support Quality audits and health authority inspections and ensure any resulting corrective and preventative actions (CAPA) are effectively implemented. /ppbPrimary Activities /b /pulliServe as a subject matter expert for current good manufacturing practice (CGMP) requirements for vaccine and large molecule manufacturing /liliPartner with our Company and CMO management to identify appropriate CAPA to address findings identified during audits and inspections. Monitor CAPA status and ensure CAPA are implemented in accordance with commitments. Perform independent verification of CAPA implementation and effectiveness to ensure no recurrence of findings /liliGather regulatory intelligence and partner with our Company and CMO management to prepare sites for audits and inspections. Assists sites during audits and inspections to ensure successful outcomes /liliMonitor and analyze the outcomes of audits and inspections to identify, investigate, and resolve trends. Report results to Divisional and Regional Quality / Management councils /liliProvide guidance and consultation services for regulatory reporting (e.g., BPDR, DPR) /liliAuthor and / or review global standards and procedures related to biologics, vaccines, and finished product ensuring compliance with regulatory requirements /liliActively participate in industry organizations such as PDA, PQRI, PhRMA, ISPE, etc. /li /ulpbEducation and Required Experience : /b /pulliBachelors degree in Life Sciences, Chemistry, Engineering or related relevant discipline and 10+ years of demonstrated experience within Quality compliance within large molecule manufacturing industry /liliExpert knowledge of GMP requirements for multiple regulatory agencies /liliExpert knowledge of large molecule manufacturing processes (for biologics and / or vaccines) and sterility assurance requirements /liliAbility to accurately interpret and apply regulatory expectations for a robust and compliant QMS /liliExperience in health authority inspections /li /ulpbRequired Skills : /b /pulliDrive Results – set clear performance standards, overcome obstacles; accountable for actions and achieve results /liliMake Rapid, Disciplined Decisions – demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions /liliAct with Courage and Candor – ability and willingness to advocate for compliance position using objective evidence, escalates issues and decisions, as appropriate /liliFoster Collaboration – ability to influence, facilitate groups with diverse perspectives, bring teams to consensus / alignment /liliMake Rapid, Disciplined Decisions – demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions /liliAct with Courage and Candor – ability and willingness to advocate for compliance position using objective evidence, escalates issues and decisions, as appropriate /li /ulpbPreferred Skills / Experience : /b /pulliExperience working for a health authority as an inspector, investigator, compliance officer, reviewer, or assessor /liliExperience creating or assessing remediation plans /li /ulpEBRG /ppCurrent Employees apply /ppbUS and Puerto Rico Residents Only : /b /ppOur 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. /ppAs 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 : /ppEEOC Know Your Rights /ppbEEOC GINA Supplement /b /ppWe 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. /ppLearn more about your rights, including under California, Colorado and other US State Acts /ppbU.S. Hybrid Work Model /b /ppEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. /ppThe salary range for this role is /ppb169,700.00 - $267,200.00 /b /ppThis 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. /ppThe successful candidate will be eligible for annual bonus and long-term incentive, if applicable. /ppWe 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 p /ppbYou can apply for this role through a /b /ppor via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. /ppSan Francisco Residents Only : We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance /ppLos 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 Ordinance /ppbSearch Firm Representatives Please Read Carefully /b /ppMerck 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. /ppuEmployee Status : /u Regular /ppuRelocation : /u No relocation /ppVISA Sponsorship : /ppTravel Requirements : /ppFlexible Work Arrangements : /ppRemote /ppuShift : /u 1st - Day /ppValid Driving License : /ppN / A /ppbRequired Skills : /b /ppBiological Sciences, Biologics, Biopharmaceutics, Corrective and Preventive Action (CAPA), Detail-Oriented, Driving Continuous Improvement, GMP Compliance, Manufacturing, Pharmaceutical Quality Control (QC), Preventive Action, Quality Assurance (QA), Quality Assurance Auditing, Quality Assurance Inspection, Quality Control Inspection, Quality Management, Quality Management Systems (QMS), Quality Metrics, Regulatory Compliance, Regulatory Inspections, Vaccine Manufacturing /ppPreferred Skills : /ppQuality Control Reviews, Remediation Plans /ppJob Posting End Date : /ppb07 / 27 / 2025 /b /pulliA 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. /li /ulpuRequisition ID : /u R355668 /p #J-18808-Ljbffr