Merck Senior Specialist, Third Party Quality Management, Finished Goods Liaison in Helena, Montana
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.
The mission of Quality Assurance is to: safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies.
Working in the Finished Goods Platform TPQM (Third Party Quality Management) department within our Research & Development Division. The Senior Specialist will serve as the quality representative for and providing quality oversight of contractors performing various GMP activities supporting the production of clinical supplies, on behalf of our Company.
Quality oversight of nominated Third-Party Vendors in the Clinical Finished Goods (FG) Platform include -
Supporting internal cross-functional investigation and resolution teams.
Reviewing and approving of contractor-initiated investigations associated with deviations.
Negotiating site and global Technical and Quality Agreements,
Participating in contractor GMP audits, supporting the collection of related metrics
Assisting in contractor “deep dive” quality assessments such as data integrity and cross-functional contractor performance reviews for the platform.
Collaborating with external contractor quality and technical personnel.
Interacting with Quality Disposition, Global Clinical Supply Groups, Pharmaceutical Research/Development, and Procurement on strategic objectives linked to external contractors including GMP qualification as well as site/project selection.
Working on projects related to quality oversight of vendors such as development of key quality performance metrics.
Serving as a quality representative in oversight and business review meetings with members from our company and contractor personnel to discuss projects, financial, operational/quality and overall performance topics.
In addition to the job specific assignments discussed above, the Senior Specialist is expected to independently execute the following -
The global maintenance and accuracy of the Development Approved Vendor Listing.
Establishment Management and impact assessment of supplier related changes and identification of opportunities for further improvements and streamlining.
Support of cross functional impact assessments using risk-based tools for significant vendor related events.
Planning and facilitating Quality-related process reviews and/or investigations under minimal supervision.
Communicating with senior management within our Company and the contractor organization.
Facilitates and/or prepares cross-functional management presentations.
Making independent decisions and acting with authority to carry out tasks.
Identifying trends and/or potential compliance gaps and proactively leads the resolution of issues affecting quality and efficiency.
Interpreting regulatory requirements for various audiences, including source area management, and facilitating communication of these requirements across stakeholders.
- Bachelor’s Degree in Engineering, Biology, Chemistry, or related field.
A minimum of 7 years of relevant experience within the pharmaceutical industry OR
Advanced education with a minimum of 5 years relevant experience.
Preferred Experience and Skills:
Experience interacting with regulatory officials and external auditing parties.
Strong compliance knowledge of EU/US/ROW regulations coupled with proficiency in interpreting and applying GMPs to a R&D environment
In-depth knowledge of regulatory agency regulations and requirements
Ability to independently interact with external auditing parties
Possess drug development knowledge
Demonstrated knowledge of continuous improvement methodologies
Ability to lead matrix teams, recognize improvement opportunities, develop appropriate solutions and follow through on implementation
Strongly developed cross-functional teamwork, partnership, influencing and negotiation
Excellent communication skills (oral and written) to work effectively with diverse individuals/groups.
Demonstrated time management skills, ability to conduct well defined projects within discipline or area of expertise
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
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.
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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.
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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.
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Requisition ID: R181171