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Job Details


Merck & Co. Inc.

Associate Director , Live Virus Vaccine E2E Environmental Monitoring Quality Lead

Pharmaceuticals

All

Full Time

On Site

No

West Point, Pennsylvania, United States

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

The Quality Environmental Monitoring (EM) Lead will provide management of the End to End (E2E) Live Virus Vaccine (LVV) EM team, the EM program for Operations of LVV & Shared Services & Incoming Materials (SS/IM) products, regulatory inspection support, and initiation of sterility assurance initiatives at the site. The individual in this role is a member of the E2E Quality leadership team, the EM Center of Excellence (CoE), and additional site leadership teams. This role will be responsible to drive LVV & SS/IM E2E compliance to critical EM business processes/systems and critical programs designed to heighten our contamination control through the use of Lean Manufacturing/Six Sigma, inclusion behaviors, and Change Execution Management.

Responsibilities

  • Manage a team of ~15 EM specialists executing tactical and strategic EM objectives for LVV & SS/IM E2E Operations | Develop a high performing team through real time coaching; ensure each team member has a meaningful and up to date personal development plan

  • Work cross-functionally with Operations, Technology, and Quality to identify and remediate EM issues within the LVV E2E, SS/IM E2E and West Point site identified during self-audits, regulatory inspections, process deviations, Quality Manual Gap assessments, or as part of continuous improvement.

  • Act with a high degree of autonomy as the LVV & SS/IM E2E subject matter expert empowered to make decisions and recommendations on behalf of the LVV E2E on matters relating to our Company’s EM procedures and policies

  • Support approvals of EM Protocol & Report approvals, review & approval of Quality Notifications, Corrective actions and Change Control Documents

  • Manage emerging EM Issues for the LVV E2E, SS/IM E2E or West Point site, present to regulatory authorities and Senior Site Leadership and represent our Company in external associations

Education

  • Bachelor degree in microbiology, molecular biology, biochemistry, biology, biological engineering, or related areas of study.

Required

  • At least five years of relevant work experience in the pharmaceutical/biotech industry

  • Prior people management experience

  • Demonstrated strong problem identification and solving skills

  • Aseptic processing/sterility assurance experience

Preferred

  • Lean Manufacturing/Six Sigma, talent development, domestic/international regulatory agencies, project management, and change execution management

  • Sterile operations experience in manufacturing sterile biologic or pharmaceutical product

  • High technical aptitude and experience in the design, development, implementation and sustainment of an Environmental Monitoring and Cleanroom Conduct program

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., 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 …

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 [Register to View] 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.

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Current Contingent Workers apply [Register to View]

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 [Register to View] if you need an accommodation during the application or hiring process.

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

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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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R134264