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Full-time
bachelor degree
Posted 56d ago
Apply by Jun 24
~40 hrs/week
Responsibilities
Lead a team of quality managers and specialists to oversee API quality operations, including batch record review, release, and deviation management. Ensure high standards of compliance and inspection readiness while driving key quality initiatives and managing operational KPIs.
Requirements
Requires a Bachelor's degree in Science, Engineering, or a related field with at least 10 years of experience in pharmaceutical quality operations. Must have a minimum of 5 years of people management experience and expert knowledge of regulatory standards for Singapore, EU, or US markets.
Full job description
Job Description
The position of Associate Director in Quality Assurance (API IPT) will play a key role in leading a team of quality manager/specialists and managing the respective Quality operations comprising, but not limited to, annual product review, batch record review and release, deviation management and oversight of operations and testing activities. The role will ensure and maintain high standards of quality and compliance within our organization.
WHAT YOU WILL DO
Essential Functions and Responsibilities (includes, but are not limited to):
The Associate Director, Quality Assurance is responsible for:
Organize and administer the batch review/release related activities to provide efficient, timely and reliable release in accordance with approved procedures.
Ensure day-to-day quality support/guidance to operations/lab including quality decisions for manufacturing/testing related events on the shopfloor. Responsible for Quality representative at cross functional tier meetings and GEMBA.
Approval of deviations and their associated CAPAs according to deviation management procedures. Oversight on the deviation trend and metrics.
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 operational requirements and financial budgets.
Responsible for training, performance management, development and coaching of direct reports.
Ensure consistent execution of safety programs to maintain a safe working environment.
The Associate Director, Quality Assurance is also responsible for:
Strategize and lead key Quality initiatives per Hoshin deliverables
Manage escalations and stakeholders for the respective operations, including financial targets and related efficiency and productivity KPIs for the overall team.
WHAT YOU MUST HAVE
Qualification and Skills Requirements (Includes but are not limited to)
Qualifications & Experience
Bachelor’s degree in science/ Life Science, Pharmaceutical Science, Engineering or proven relevant experience.
Minimum 10 years of applied professional work experience in the quality operations in pharmaceutical manufacturing, with at least 5 years of people management experience.
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/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
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Strong communication and interpersonal skills.
Passionate in coaching and mentoring with a focus on creating an inclusive 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:
Adaptability, Adaptability, Change Management, Corrective Action Management, Cross-Cultural Awareness, Cross-Functional Teamwork, GMP Training, Good Distribution Practice (GDP), Human Resource Management, Inspection Readiness, Manufacturing Quality Control, Organizational Performance Management, People Management, Pharmaceutical Manufacturing, Quality Assurance (QA), Quality Auditing, Quality Control Management, Quality Initiatives, Quality Management, Quality Management Standards, Quality Metrics, Quality Systems Compliance, Regulatory Compliance, Resource Management, Risk Management {+ 1 more}
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:
06/24/2026
*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.
Related keywords
APIQuality AssuranceGMPGDPCAPADeviation ManagementBatch ReleaseRegulatory ComplianceHoshinGEMBAPharmaceuticalsQuality MetricsInternal AuditsExternal AuditsLife SciencesQuality Systems
At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Facebook, Instagram, Twitter, and YouTube.
Offices: 90 E Scott Ave, Rahway, New Jersey 07065, US · 2000 Galloping Hill Road, Kenilworth, NJ 07033, US · Jalan Puteri 5/20, Puchong, Selangor 47100, MY · Clos du Lynx 5, Woluwe-Saint-Lambert, Brussels Region 1200, BE · Keilaranta 3, Espoo, Southern Finland 02150, FI
Animal FeedVeterinaryHealth CareData ManagementBiopharmaClinical TrialsBiotechnologyMedicalPharmaceuticalData Center Automation
How many Healthcare jobs are open in Singapore, Singapore right now?
There are currently 985 open healthcare positions in Singapore, Singapore listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Singapore, Singapore?
Companies currently hiring include SingHealth, GSK, Thermo Fisher Scientific, National Institute of Education, Singapore, Sanofi, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Singapore, Singapore?
Yes — 120 of the 985 open healthcare positions offer remote or hybrid work (19 remote, 101 hybrid).
How do I apply for Healthcare jobs in Singapore, Singapore?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.