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Associate Director, External Site Quality Lead

Merck Cherokee

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Rahway, NJ
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Job Description

As posted by the hiring company

Job Overview:

Job Description

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.

We are seeking a Growth and Improvement minded External Site Quality Lead Associate Director that can help drive our Strategic Operating Priorities.

  • Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

  • Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

  • Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

  • Diverse Talent | We are dedicated to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

  • Values and Standards | Our Steadfast Dedication to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Strategic Summary

An amazing opportunity has arisen for an External Site Quality Lead Associate Director for New Product Introduction to join our team. As a company we are dedicated to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. This position will contribute to supplier selection for new products involving medical devices and drug delivery systems for use in combination products and will facilitate third party site readiness for timely submission of product filings that involve medical devices and combination products under External Manufacturing oversight.

The successful candidate is position is accountable for implementing Quality Assurance policy and discharging Quality responsibilities for the oversight of contract manufacturing organizations that supply medical device components or combination products.

Key Responsibilities

Bring energy, knowledge, innovation and leadership to carry out the following:

  • Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

  • Leadership role in monitoring and maintaining contracted third-party compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign), and other pertinent legal requirements, including applicable ISO accreditation

  • Quality oversight of contract manufacture, testing, packaging, storage, and/or distribution of combination products or medical device components; executed under the direction or on behalf of the External Quality Assurance Director

  • Assuring that products are manufactured from approved processes in conformance to all applicable regulatory requirements and Company policies, and may include the release of manufactured products

  • Ensure the quality performance of Contract Manufactures through direct oversight, support and technical advice, counselling to the third-party site senior leadership and providing on-site supervision

  • Participation in activities such as third-party selection, facility Due Diligence, and negotiation and establishing of Quality Agreements

  • Participate in applicable device design control lifecycle and partner in successful design transfer for commercial production

  • Provide support to build effective Quality Management Systems and drive continuous improvement activities at the Contract Manufacturer, related to medical device component and/or combination product regulatory expectations; and maintain compliance with the Quality Agreements between the parties

  • Drive partnership within internal and external cross-functional groups to achieve objectives and communicate company expectations as necessary to improve relationship performance against agreed upon metrics and business goals

Education

  • Bachelor's degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or related disciplines

Required

  • Eight years of experience working in the Pharmaceutical industry, with strong knowledge of and expansive experience in Quality Assurance and Quality Control activities, particularly applied to drug delivery systems, medical devices and/or combination products.

  • Experience in Quality Agreement development and cross-functional teamwork is required. Familiarity and experience in the application of ISO 13485 and ISO 14971

  • Principled verbal and written communications

  • Demonstrated personal networking and relationship building skills

  • Conversant on domestic and foreign regulations and compendia governing manufacturing operations particularly applied to drug delivery system/medical device Quality Management Systems.

  • Working in ExM QA environment

  • Negotiating 3rd Party Quality Agreement requirements specific to Medical device / Pharmaceutical Products / Combination Devices, and prior experience in the oversight of 3rd Party suppliers

  • Must have demonstrated experience with managing KPI’s and communicating performance indicators to management and stakeholders

Preferred

  • Quality oversight of plastic molding operations or combination product manufacture

  • Experience with autoinjectors and/or inhaler devices

  • Contractual and financial awareness

  • Experience in Lean project implementation and Project 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 …

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.

Residents of Colorado

Click here to request this role’s pay range.

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.

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.

Residents of Colorado:

Click here to request this role’s pay range.

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:

No relocation

VISA Sponsorship:

Travel Requirements:

25%

Flexible Work Arrangements:

Remote Work

Shift:

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1