Manager, Quality COE - Lab Support SDLC

Job description

Job Description The position will play a key role in leading a team of quality specialists managing Laboratory System Qualification. The role will ensure and maintain high standards of quality and compliance within our organization. In this role, you will be responsible for the key responsibilities below: Laboratory System Qualification Lead the laboratory system lifecycle management, including system qualification/retirement, commissioning/decommissioning, calibration and maintenance, system administration, and periodic reviews, in accordance with approved procedures and standard lead time. WHAT YOU WILL DO Responsibilities Oversee and lead key functions and Quality initiatives to improve Quality and Safety compliance, work efficiency, and cost savings. Manage the financial budgets and spending on total maintenance and repair (MRO) and CAPEX. Ensure inspection readiness of the area for self-inspections, internal and external audits, and timely follow-up on corrective actions and commitments resulting from inspections. Plan and manage resource utilization to optimize efficiency, meeting operational requirements and financial budgets. Responsible for training, performance management, development, and coaching of direct reports/contractors. Manage escalations and communicate with senior stakeholders regarding operations, including financial targets and related efficiency and productivity KPIs for the team. Drive collaboration and promote a transformational culture change within the organization. Review and approve quality documentation, such as change control, deviations, protocols, and summary reports. Ensure consistent execution of safety programs to maintain a safe working environment. Any other duties as assigned by reporting manager. WHAT YOU MUST HAVE Qualifications & Experience: Bachelor’s degree in Science/ Life Science, Pharmaceutical Science, Engineering or proven relevant experience. Minimum 7 years of applied professional work experience in the quality operations in pharmaceutical manufacturing. Strong knowledge of laboratory systems, calibration, maintenance, and administration. Demonstrated experience in change and project management with ability to lead a cross functional high-performance team. Experience and expert knowledge of regulatory standards, compliance procedures and quality systems especially for Singapore, EU or US markets. Experience in managing financial budgets and controlling costs. Proven ability to manage and develop a team. Personal Qualities: Demonstrated people management skills and ability to influence/collaborate with stakeholders at senior levels. Customer focus with strong business acumen and continuous improvement mindset. Strategic and critical thinking mindset with a collaborative and problem-solving attitude. Strong communication and interpersonal skills. Attention to detail and ability to prioritize tasks effectively. Passionate in coaching and mentoring with a focus on creating an inclusive quality culture. Who we are We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today. Required Skills: Analytical Method Transfer, Analytical Testing, Analytical Thinking, Budget Management, cGMP Compliance, Corrective Action Management, Driving Continuous Improvement, GMP Documentation, Inspection Readiness, Instrumentation, Laboratory Equipment Calibration, Laboratory Information Management System (LIMS), Laboratory Operations, People Leadership, Periodic Reviews, Pharmaceutical Manufacturing, Pharmaceutical Quality Control (QC), Project Management, Quality Initiatives, Quality Standards, Regulatory Compliance Consulting, Team Mentorship, Team Supervision, Technical Writing Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search 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: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 06/30/2026 *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.