Assoc. Dir, Quality Assurance - API IPT

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
• undefined
• 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}

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:

06/24/2026

*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.