Merck Integrated Product Team Quality Lead in West Point, Pennsylvania
New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
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 committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Integrated Product Team (IPT) Quality Operations Leader reports to the End to End (E2E) Quality Operations Director and is responsible for Quality oversight of vaccine formulation and filling operations. The qualified candidate ensures IPT compliance to Divisional, Company, and Site standards and procedures. The incumbent manages a team of Quality Specialists, responsible for shop floor audits, batch record review, batch disposition, and Quality approvals for deviation management and change control.
This role partners with the IPT Operations and Technical Operations Leaders to ensure that products are manufactured according to approved processes and comply with all applicable regulatory and internal requirements. The qualified candidate must demonstrate strong analytical and scientific acumen in order to assist with troubleshooting of manufacturing processes. Excellent management capabilities, including cross-functional collaboration, written and verbal communication skills, structured problem solving, disciplined decision-making, and talent management are required. The incumbent will actively participate in external regulatory inspections and is a member of the IPT and End-to-End Quality Leadership Teams.
Manage and coach the IPT Quality team (direct and indirect reports) to deliver strong results while developing individual and team capabilities
Ensure that all team members operate safely and comply with established safety and environmental policies and procedures (Corporate, Site, and Governmental)
Serve as the primary Quality Operations contact for the IPT and represent the IPT on local and site governance committees, including IPT and End to End Leadership Teams, Technical/Operations Reviews, and regulatory forums
Acquire and maintain technical process knowledge relevant to IPT operations. Ensure that documentation and products manufactured in the IPT comply with all applicable standards and procedures, and governing regulations
Proactively partner with Operations, Technology, and Maintenance to identify and implement continuous improvement actions to reduce deviations, reduce lead-time, and eliminate waste, while maintaining compliance
Review and approve deviations, corrective / preventative actions, commitments, change requests, and other Quality documents
- Bachelor degree in science, engineering, or related area of study
Minimum five years’ in the Pharmaceutical industry
Minimum one year in a supervisory/management role
Quality Management Systems (QMS) and regulatory inspections
Three years’ in a supervisory/management role
Organizational design and talent development
Aseptic/sterile processing experience
Quality or Operations experience in Pharmaceutical, Biologics, Vaccines, or Therapeutic Protein manufacturing
Demonstrated leadership experience working with cross-functional teams
Digital literacy and demonstrated problem solving capabilities
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 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.
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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., 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.
No Travel Required
Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R151589
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