AVP, Global Pharmaceutical Operation (GPO) (EQA) External Quality Assurance

Job Description

"As a science-based healthcare company with a longstanding commitment to inventing and providing important medicines and vaccines, subject to local law, we will require all U.S. and Puerto Rico based employees to be vaccinated by November 1, 2021, unless they have an approved medical or religious exemption or accommodation. We are committed to supporting our employees during this process as we work to ensure a safe and healthy work environment."

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals 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.

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.

The AVP, Global Pharmaceutical Operation (GPO) (EQA) External Quality Assurance leads a multi-national team of more than 90 professionals responsible for Quality management of our Company's Global External Manufacturing Network. Provides leadership and direction on all policies, guidelines and systems for the achievement of GMP compliance. Ensures that all products manufactured at external partners (> 100 external manufacturing sites spanning API, Non-Sterile Pharm, and Devices) and alliances 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. Drives for consistency, sharing of best practices and alignment of Quality and business processes associated with all external partners. Responsible for establishing and maintaining all aspects of an organization of Quality professionals that ensures the quality performance of external contract manufacturing partners through direct oversight, support and technical advice, counseling to the partners' site senior leadership and providing on-site supervision as appropriate. This includes ensuring appropriate Quality systems and guidance are in place for Partner Selection and GMP Due Diligence including establishing Quality Agreements; Quality Assurance including permanent audit readiness, providing coaching and training; Quality Control such as product release, atypical investigations and change control approval.

Primary Activities

Primary activities include, but are not limited to:
  • Works strategically and in collaboration 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 >120 external manufacturing sites across the globe, and spanning API, pharmaceutical, packaging, and devices.
  • Responsible for the strategy, leadership, management and budgetary controls of a multi-cultural team of more than 100 Quality professionals located globally.
  • Accountable for release or the coordination of release of product manufactured at External Suppliers in accordance with worldwide regulatory requirements.
  • Responsible 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 and 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.
  • Oversees quality due diligence assessments for pre-approval considerations of 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.
  • Establishes and chairs External Manufacturing Quality Council and effectively communicates issues which impact Quality and GMP compliance.
  • Participates as a member of the senior Global Pharmaceutical Ops Quality and External Manufacturing Leadership Team and other committees as appropriate.


Education Requirement:
  • BS (advanced degree preferred) in a relevant Science field.


Required:
  • Minimum of 10 years' experience in Quality Systems, Quality Assurance and Quality Control involving pharmaceutical manufacturing operations in compliance with global GMP and health regulatory requirements.
  • 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.
  • Strong Compliance experience, being familiar or having personal relationships with key regulators/inspectors at FDA, EMA, TGA, ANVISA).
  • Significant Quality Operations experience (more so than QA or auditing) in Quality Labs, Batch Release, 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 to have experience with multiple manufacturing platforms (Solid Dosage, API, Pkg) in Quality or Tech Ops roles.
  • Complementary experience in, or exposure to, related functions such as Operations, Engineering, Supply Chain and Commercial.


Travel:
  • Ability to travel ~25% of the time, occasionally on short notice.


Who we are ...

We are known as Merck & Co., Inc., Kenilworth, 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 ...

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.

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

EEOC GINA Supplement​

OFCCP EEO Supplement

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., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Travel Requirements:
25%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R146708