Manager, Quality Control (Chemistry)

Job Description

Under general direction of the Director, Wilson Quality Control, the Quality Control (Chemistry) Manager is responsible for leading a team of 6-10 professionals who make up the North America Stability Unit-Wilson testing team. The North America Stability Unit -Wilson testing team performs stability testing, release testing and API testing as well as laboratory investigations and continuous improvement activities to ensure that customer expectations are met or exceeded while complying to compliance and cGMP regulations. The Quality Control Manager will drive continuous improvement and supports sustainability of implemented changes identified through lean tools or from other efforts. Responsible to implement productivity enhancements to streamline activities to meet or exceed customer expectations.

Responsibilities of the Manager, Quality Control (Chemistry) include but are not limited to:

• Aligning resources with business unit needs.
• Actively participating in Plant/Quality committees and working with other quality groups, Planning, Manufacturing, Packaging, Maintenance, and others as required to resolve problems, and satisfy quality and production needs.
• Knowledge of cGMP’s, and laboratory safety, as well as the transfer of that knowledge to employees.
• Routinely making decisions using cGMP and safety knowledge as a guide.
• Editing, writing, and/or approving departmental SOPs and investigations.
• Acting as a key regulatory compliance liaison to interface with regulatory agencies during audits of assigned areas.
• Performing duties and responsibilities of the Director in his/her absence.
• Reporting to the Quality Control Director for general advice and instruction, but normally handles routine matters independently, consulting on major problems only.

Administrative and personnel actions such as hiring, transfers, training, salary and appraisal administration.

• Managing activities to identify and correct problems, emphasizing prompt and definitive resolution to minimize adverse impact and re-occurrence.
• Managing the Quality Control area in accordance with company policy and applicable government regulations.
• Making provisions to assure job responsibilities of the Quality Control area are conducted in a timely and reliable manner to meet production demands.
• Ensuring that all contemporary policies (SOPs, methods, Departmental Policies,) are maintained and adhered to within the laboratory.
• Participating in the generation and interpretation of divisional policies/guidelines.
• Supporting initiatives that involve the necessary human and capital resources needed to meet present and future Quality Control needs and managing those resources to meet annual profit plan.
• Supporting the achievement of plant objectives (e.g., metrics, productivity, etc.).
• Applying leadership principles to testing operations.
• Leading laboratory Data Services team.
• Leading deviation management, OOS/OOT
• Performs other duties as assigned.

Education Minimum Requirements

• Minimum B.S. in science/Engineering or related field

Required Experience and Skills

• A Minimum of five (5) years of experience in a GMP pharmaceutical laboratory.
• Thorough knowledge of plant-wide systems and processes.
• Must be able to provide technical direction and training to include Good Manufacturing Practice, safety practices, and good documentation practices as they relate to the quality assurance of the product.
• Must have prior expert level experience in LC (HPLC, UHPLC), GC, empower, method validation/transfer, titration, dissolution, content uniformity, data integrity requirements, OOS/OOT investigations etc.

Preferred Experience and Skills

• A minimum of two (2) years supervisory experience recommended.
• Experience writing reports, managing projects/resource and time management.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

If you need an accommodation for the application process please email us at staffingaadar@merck.com