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Director, Quality Assurance
3 weeks ago
**Director, Quality Assurance**
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 committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
**THE OPPORTUNITY**
In this role, you will be responsible for all or subset of the key responsibilities below:
- Leading a team of Associate Directors and Senior Managers, responsible for Quality Management Systems (QMS) and Compliance comprising of internal and external audits, quality and enterprise management systems, DI and QRM
- Leading a team of Associate Directors and Senior Managers, responsible for various quality support labs responsible for lab maintenance, SDLC, change controls, stability, complaints, supplier management and trending.
- Responsible for the overall strategy, performance and results for the Quality Support teams while driving site quality culture.
- Drive collaboration and transformational culture change.
- Setting overall strategy and direction of the QMS and Compliance teams, aligned with business vision and plan.
- Lead the team to ensure successful outcomes of quality support teams towards value stream teams (VSM).
- Overall responsibility for training, upskilling and career development needs are addressed for each direct report as well as the wider team.
- Partner with VSM, business, internal and external auditors for overall systems and compliance activities, including financial targets and efficiency and productivity KPIs for the overall team.
- 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’s or master's 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, with ability to lead a cross functional high‐performance team.
- Experience in leading quality operations and knowledge of, compliance procedures and quality systems especially for Singapore, EU, or US markets.
**Personal Qualities**
- Demonstrated people leadership skills and ability, influence and collaborate effectively with stakeholders across the organization.
- 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.
**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.
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**Employee Status**:
Regular
**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Hybrid
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R290802