Job Description

Job Description

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.

This position reports to the Associate Director, Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications in relation to complex/niche supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc.

Responsibilities may include, but are not limited to, the following:

* Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations.

* Coordinate and/or support the preparation of procedures, processes and quality improvements.

* Assists in the coordination of significant quality events including fact finding, investigation, coordination of clinical quarantine and recovery actions.

* Collaboration across cross-functional and business areas to ensure robust processing, continuous improvement and cross-functional team building.

* Providing on-the-floor coaching/guidance of operational and technical issues; providing immediate resolution on the shop floor to deviations and potential deviations.

* Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve outcomes, reduce cost, or lower our processing cycle times.

* Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.

* Actively using and championing the use of Lean Six Sigma (LSS) and our Company's Production System (PS) tools, both in problem-solving and day-to-day operational activities.

Education Minimum Requirements:

* Bachelor's degree with a technical emphasis in an appropriate scientific or engineering field preferred.

Required Experience and Skills:

* Minimum of 5 years post-degree experience in the Pharmaceutical or equivalent industry Good Manufacturing Practice (GMP) related field including Technical, Engineering, Quality or Operations.

* Familiarity with batch disposition (release) activities is a strongly preferred skill necessary for success in this position; prior batch disposition experience is a plus.

* Prior experience reviewing and approving investigations, deviation management support, and Corrective/Preventative Actions (CAPAs) is a plus and a strongly preferred skill.

* Previous experience in quality control, quality assurance, auditing or regulatory affairs.

* Effectiveness and creativity in approaching and solving technical problems.

* In-depth working knowledge of current Good Manufacturing Practices (cGMPs) and of regulatory requirements as they apply to the pharmaceutical field or a related area.

* Basic understanding of the use and maintenance for Microsoft applications (such as MS Excel, Outlook, and/or MS Access).

* Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.

* Demonstrated teamwork skills and ability to work independently.

* Attention to detail, flexibility and an awareness of production and quality control problems.

Preferred Experience and Skills:

* Ability to independently manage multiple priorities and projects.

* Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives.

* Demonstrated analytical and problem-solving skills, experience in Lean Six Sigma and Project Management.

* Computer skills; knowledge and competency in ERP/MES, Trackwise, SAP, PowerPoint, Excel and Word.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science and that great medicines can make a significant impact to our world. And 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., 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

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

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:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

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 anothers 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:

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R96471