Job Description

The position of Director, Quality Operations, plays a significant role in the definition of the quality strategy and key business objectives and has a strong direct impact on the execution of strategy. The role sits as a key succession role for the Site Quality Head and the incumbent is a key member of the Quality Leadership team, leading diverse teams providing end to end services to IPTs.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

This role is responsible for:

End to End oversight across Quality Operations for the Singapore facility which includes multiple product modalities

Leading a team of Associate Directors and Senior Managers, responsible for Quality Assurance and Quality Control, with oversight across operations including various quality labs supporting IPTs e.g., API/Incoming/OSD/Component labs, Batch Review/Release, Floor Support, Deviation Management and change control.

Responsible for the overall strategy, performance, and results, while driving site quality culture

Driving collaboration and transformational culture change

Key Responsibilities, all or subset of the below:

Setting overall strategy and direction of quality operations, aligned with business vision and plan

Lead a team of Quality leaders and managers to ensure successful outcomes aligned with business strategy

Overall responsibility inspiring the quality operations organization and developing leaders, career pathing, and building strong succession plans for future

Engagement and stakeholder management is an essential part of the role, working with IPT leader and cross functional and functional business leaders for overall quality operations, including financial targets and efficiency and productivity KPIs

Accountable for the change control and management of above site escalations, including risks and issues management

Actively identify opportunities to collaborate with business and other Quality Directors and encourage/support teams for continuous improvement

Lead and drive site quality culture

What are we looking for?

Qualifications & Experience

Bachelor or Master\xe2\x80\x99s degree in Science/ Life Science, Pharmaceutical Science or Engineering or proven relevant experience.

12-15 years of applied professional work experience in the following pharmaceutical work areas: quality operations, quality support and compliance

Demonstrated experience in business and functional strategy and key strategic objectives / metrics while aligning priorities and resources to deliver on commitments

Leading change and project management for large teams of above 100 employees, with ability to lead a cross functional high-performance team

Experience in leading quality operations and 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 senior stakeholders

Customer focus with strong business acumen and continuous improvement mindset

Strategic and critical thinking mindset with a collaborative and problem-solving attitude

Experience with project and change management

Coaching and mentoring with a focus on creating an inclusive quality culture

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that\xe2\x80\x99s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

Who we are \xe2\x80\xa6

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 \xe2\x80\xa6

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\xe2\x80\x94and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another\xe2\x80\x99s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply

Current Contingent Workers apply

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: Domestic/International

VISA Sponsorship: Yes

Travel Requirements: 10%

Flexible Work Arrangements: Hybrid

Shift: Not Indicated

Valid Driving License: Yes

Hazardous Material(s):

Merck Sharp & Dohme