Manager, Quality Operations (API-FDS Lab)

Job Description

The position of Manager in Quality Operation will play a key role in leading a team of quality specialists/technicians and managing the Quality Laboratory. The role will ensure and maintain high standards of quality and compliance within our organization.

In this role, you will be responsible for all or subset of the key responsibilities below:

• Ensure that analytical, microbiological testing of incoming materials, in-process samples, cleaning samples, environmental monitoring samples, utility systems, intermediates and finished drug substances products is performed according to approved procedures and standard lead time.
• Review and approve the implementation of new and revise Analytical Standards.
• Oversee and lead analytical, microbiological method transfer, validation, verification, new product introduction and equipment qualification.
• Ensure inspection readiness of the area with respect to all self-inspections, internal and external audits. When required, provide responses and timely follow-up on relevant corrective actions and commitments made because of the inspections.
• Manage and plan resource utilization to ensure optimal efficiency to meet operation requirements and financial budgets.
• Responsible for training, performance management, development and coaching of direct reports.
• Manage escalations and senior stakeholders for the respective operations, including financial targets and related efficiency and productivity KPIs for the overall team.
• Drive collaboration and transformational culture change.
• Strategize and lead key Quality initiatives such as implementation of model areas and digitalization.
• Review and approve Quality documentation such as change control, deviations, protocols and summary reports.
• Ensures consistent execution of safety programs to maintain a safe working environment.

What are we looking for?

Qualifications & Experience

• Bachelor’s degree in Science or Life Science, Pharmaceutical Science, Engineering or proven relevant experience.
• Minimum 7 years of applied professional work experience in the quality operations in pharmaceutical manufacturing.
• 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.

Personal Qualities

• Demonstrated people management skills and ability to influence and 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.
• 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 inventing for life, 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.

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: 01/10/2025

*A job posting is effective until 11:59:59 PM 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.

Requisition ID: R329255