Job Description

Director, Quality & Compliance -Project Vision \xe2\x80\x93 India

The Director, Quality Assurance Lead will work with the Operations Lead to help CMO establish the quality culture and mutually agreed to Quality Management System. This will include helping the CMO select digital QMS tools, establish controls to assure data integrity that meets WHO and EMA expectations, facilitate technology transfer, and assure systems and metrics are in place to provide remote continuous oversight. The lead will manage a local team and work with global subject matter experts.

WHAT WILL YOU DO:

Strategic Oversight

• Help CMO build Quality Culture compatible with the company and Competent Health Authority\xe2\x80\x99s expectations.
• Plans and helps select in consultation with the company and CMO staff foundational GMP systems to be installed at CMO.
• Provide input into CMOs, GMP improvement plan, talent acquisition plan, and training plan.
• Plans and helps build Quality Council Oversight and metrics
• Ensure CMO builds sustainable inspection readiness program.
• Mentor and coach India based staff at the company and CMO on US FDA, EMA, and WHO concepts of Quality Maturity & Quality Culture.

Operational Oversight

• Supervise local Quality staff hired to support Project Vision

• Represent Quality in Project vision meetings with CMO

• Communicate with Quality SMEs and develop resource plans.

• Coordinate lab related Project Vision activities with Global Quality Shared Services.

Qualifications:

Required to have a bachelor\xe2\x80\x99s degree in science, Technology, Engineering or equivalent. Required to have 10+ years of Quality & Compliance experience in a large reputable multinational Pharmaceutical/Biopharmaceutical/ Medical Device industry. Experience deploying GMP IT systems, hosting health authority inspections from WHO- Stringent Health Authorities, and CMC preferred.

• Experience of working in the US in the Quality Unit of Fortune 100 company will be an advantage.

• Should have dealt with complex business processes and GxP compliance requirements

• Should have a commitment to build a strong local leadership team combined with the ability to nurture and retain top talent.
• Desire to build a result and success-oriented culture.
• Ability to plan strategically and to execute on that plan.

The ideal candidate should possess the ability to understand business dynamics and suggest / provide solutions.

Excellent communication skills - should possess the ability to articulate thoughts precisely and concisely. S/he should be able to bridge the gap between the technological and business thought processes and display an ability to be persuasive. S/he should also have good listening skills.

Hands on approach - should be a strong driver in the system with a keen eye on success variables. S/he should have strong project, process and business management skills and the ability to take immediate decisions.

Maturity - should display a high degree of maturity in decision-making and influencing. S/he should be able to inspire confidence among regulators, in his / her the company and CMO colleagues and influence, guide and motivate people.

Sensitive to cultural differences - ability to blend in an international environment and communicate effectively with superiors & peers from various nationalities.

Leadership - good team builder and team player. Ability to understand strengths and weakness of the team and act appropriately. Motivate and build a strong internal team. Though the position requires capability to manage the business without direct supervision, it will keep the Manufacturing Leadership stakeholders informed of all actions taken, progress made and concerns as they arise.

Strategic Orientation The ideal candidate must have a strong track record of developing and leading major strategic initiatives, focusing on core business issues, defining challenges and goals, and setting strategic direction to accomplish immediate, mid-range and long-term objectives. The ideal candidate should hit the ground running and have an immediate impact in supporting the project.

Team Leadership The ideal candidate is a leader who has built and led high-performance, business-oriented teams that have a sense of urgency, a focus on results and a commitment to quality. Success in developing people is a hallmark of this individual\xe2\x80\x99s management style. S/he must be open, communicative, yet firm with a driving leadership style, constantly raising standards. S/he will be an independent business partner and will be able to motivate, coach, develop and recruit, when necessary, a team of qualified and motivated direct reports.

Collaboration and Influencing This individual must be a strong relationship-builder and stakeholder manager both internally and externally, interacting with the business and consistently providing meaningful insight. S/he must actively demonstrate teamwork, including the ability to compromise for the greater good and the willingness to seek or invite inputs from colleagues or partners before deciding.

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

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.

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

MSD