Executive Director, External Quality

Job Description

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

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 interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Vaccine External Quality Alliance (EQA) Head is accountable for implementing Divisional and Company policy, procedures and guidelines and for discharging Quality Assurance responsibilities for our company's Global Vaccine External Manufacturing Network. Ensures that all products manufactured at external partners (drug substance, drug product, finished product) are manufactured, packaged, analyzed, released, stored and distributed in accordance with our company and all applicable regulatory requirements to meet both internal and external customer demands. Responsible for the release of all manufactured products and in assuring products have been produced from approved processes in conformance to all applicable regulatory requirements and Company policies.

Primary responsibilities include, but are not limited to:

• Accountable for the strategy, leadership, management and budgetary controls of a multi-cultural team of more than 40 Quality professionals located globally.

• Works strategically and in partnership with other functions to continuously improve our company's effectiveness and efficiency in quality management of External Partners. This includes managing all aspects of quality at external manufacturing sites across the globe, and spanning drug substance, drug product, finished product, and devices.

• Accountable for release or the coordination of release of product manufactured at External Suppliers in accordance with worldwide regulatory requirements.

• Accountable for directing and managing major External Manufacturing Quality investigations, ensures that Fact Findings are organized appropriately and co-ordinates any recalls as appropriate.

• Provides direct support and technical expertise to External Partners for the preparation for regulatory inspections and product launches.

• Provides QA/QC support such as product release, atypical investigations and charge control approval, etc.

• Reviews all audit outcomes pertaining to external manufacturers and ensures appropriate and timely corrective actions, where warranted.

• Reviews all internal and external customer complaints of our company's products which are derived from an external manufacturer.

• Establishes, through a risk based analysis, “calibrated” quality oversight based on the product type as well as the capabilities and quality performance of an external manufacturer.

• Establishes clear expectations, measures and periodic monitoring of operational and quality performance associated with External Manufacturing. Establishes periodic Quality performance review meetings with external partnerships.

• Ensures appropriate Quality systems and guidance are in place for Partner Selection and GMP due diligence assessments and establishing and maintaining Quality Agreements.

• For new external partners, ensures appropriate corrective actions are implemented and provides support to the partner in remediation of due diligence and/or pre-contract audit gaps.

• Implements and maintains a support program to build effective quality systems at each partner and provide calibrated Quality oversight, continuous improvement activities and performance monitoring to improve quality and reliability.

• Ensures the establishment and maintenance of Quality Agreements and provides expert consultation and review on commercial agreements. Possesses ultimate accountability to execute Quality Agreements and ensures delegation of authority to qualified individuals.

• Co-lead the Vaccine External Manufacturing Quality Council and effectively communicates issues which impact Quality and GMP compliance.

• Participates as a member of Vaccine Quality Leadership Team and External Manufacturing Leadership Team and other committees as appropriate.

Education:

• Bachelor's degree in science, engineering, or related area of study.

Required:

• Leadership – demonstrated ability to build relationships; develop people; lead change; inspire others; think critically; communicate clearly and create accountability.

• Minimum of 10 years’ experience in Biologics/Pharmaceutical industry; which must include aseptic/sterile processing and Quality Operations experience.

• Experience leading the Quality interface with third-party manufacturers in a regulated industry, preferably the FDA/ cGMP environment.

• Proven track record of managing complex Quality investigations, managing risk and being results driven and capable of rapid decision making.

• Experience leading inspections of both domestic and international regulatory agencies

• Significant Quality Operations experience in Quality Labs, Batch Release, Quality Assurance, Quality Systems, and more.

• Demonstrable success leading global teams; able to sense and manage diverse business cultures – both for integrating into the company and for dealing with partners

Preferred:

• Advanced Degree in a Science or Engineering field

• Experience with Vaccine or Therapeutic protein manufacturing DS, DP, and in Quality, Operations or Tech Ops roles.

• Demonstrated experience in Organization Design, Lean/Six Sigma application to Quality Operations, and Talent Development

• Experience in a start-up facility or with technology transfer

• Complementary experience in, or exposure to, related functions such as Operations, Engineering, Supply Chain and Commercial.

Travel:

• Ability to travel ~30% of the time, occasionally on short notice.

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’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

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.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

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Pay Transparency Nondiscrimination

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’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R181420