Job Details
Merck & Co, Inc
Associate Director, Specialty Product & Services | Quality Integrated Product Team Lead
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 a codependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Specialty Products and Services (SPS) Integrated Product Team (IPT) Quality Operations Leader reports to the Shared Services & Incoming Materials End to End (E2E) Quality Operations Director and is responsible for ensuring alignment to Divisional, Company, and Site policy, procedures, and guidelines for Quality Operations responsibilities within the IPT.
Responsibilities
Involve all Quality aspects associated with the IPT's manufacturing of Culture Media, Weigh and Dispense and Black Widow Antivenin including but not limited to, batch record review, release, deviation management, change control, shop floor audits and general compliance activities
The SPS IPT Quality Operations Leader manages a team responsible for the release of all SPS intermediates and products
Demonstrate strategic, team building and ethical leadership abilities with strong technical and quality understanding of processes and leverage critical thinking and problem solving to enable quality by design output of our products
Effective collaboration, communication, decision-making, and talent management are required capabilities
Participates in regulatory inspections and is a member of the IPT Leadership Teams and the E2E SS&IM Quality Leadership Team
Education Requirement
Bachelor degree in Science, Engineering or another technical field
Experience and Skills
Required
Minimum of five years’ in a functional area, such as Operations, Management, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain
Prior experience in a supervisory/management leadership capacity
Demonstrated leadership and management experience working with cross-functional teams on objectives to deliver on Key Performance Indicators and meet significant milestones
Effective at continuous improvement, lean, six sigma implementation
Demonstrated experience with quality systems such as deviation management, quality risk management, and change control
Demonstrated proven leadership experience with domestic and international regulatory agencies in a compliance/inspection setting
Preferred
Minimum three years’ in a supervisory/management capacity
Vaccine manufacturing experience
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.
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:
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:
RegularRelocation:
No relocationVISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1Requisition ID:R129436