Senior Specialist, Quality Project Manager

Job Description

Job Description

The goal of CORE (Center for Observational and Real-World Evidence) is to generate value evidence, promote both regulatory commitments and reimbursement activities and collaborate on the development of market access strategies for our company products throughout the world. The Senior Specialist role sits in the Quality Management team within the Strategy & Operations group in CORE and is part of the Non-Interventional Study Research Operations Center (NIS ROC).

Under the guidance of a Director, the Senior Specialist has the primary duty for directing the quality activities for Local Data Generation (LDG) studies as part of the NIS ROC and in close partnership with cross-functional partners including our Research Division Quality Assurance, Pharmacovigilance, and Ethics and Compliance.The Quality Manager will guide operational elements related to LDGs within the context of the Audit Taskforce, Quality and Compliance Council, Quality Control initiative, and Standards Management model under the framework of CORE’s Quality Management System (QMS).LDG Quality Manager

LDG Quality Manager

• Coordinates Audit Taskforce operations for audits and assessments related to LDGs, including alliance with our Research Division Quality Assurance (QA), Ethics and Compliance Office, local study teams, and Headquarter (HQ) Process Owners from preparation through CAPA closure.
• Fosters partnership with our Research Division QA and builds strong knowledge around GPP and GVP modules to negotiate audit findings and understand impacts and levels of risk.
• Tracks LDG audit findings and CAPAs within Trackwise system and assesses for trends across all non-interventional studies.
• Works with with ECO and our Research Division QA on ongoing quality assessments related to LDGs.
• Assesses ongoing rgulatory Inspection and Business Partner notices for LDG awareness.
• Leads Quality and Compliance Councils for significant quality issues (SQIs) involving LDGs.Champions the SQI process and SOP, increases awareness of the process and speak up culture for LDG teams.
• Partners with LDG study teams and HQ Process Owners on all Council approved CAPAs to ensure timely completion.
• Enters and tracks all SQI CAPAs in our Research Division Trackwise system and follows up with CAPA owners to ensure on-time CAPA close-out.
• Collaborates with Quality Control (QC) Partners and Process Owners to expand risk area assessments to include LDGs. Supports facilitation of QCassessments with LDG study teams.
• Partners closely with GMA in the development of LDG QMS communications, including SOP revisions/updates, and associated training plans. Monitors on time training completion for LDG study teams.
• Collaborates with Process Owners to expand resource/tool availability for LDG study teams (e.g. NIS Process Pages).
• Partners closely with LDG study teams on supplier qualification assessments prior to contract execution, tracks all qualification assessments globally.
• Prepares, QCs, and submits LDG Pharmacovigilance System MasterFile (PSMF) listings and business partner pharmacovigilance listings on routine basis. Maintains up to date required training and work instructions/job aid for the LDG PSMF process.
• Develops and monitors routine global (HQ & LDG) NIS quality metrics, reviews to monitor for trends, identify bottlenecks, and develop dashboard. Reports out results periodically to management and relevant stakeholders.
• Partners closely with Process Owners on all quality activities, including any issues and CAPAs.
• Serves as a link between the HQ Quality Management team and the NIS ROC team in Zurich for bidirectional awareness of quality issues.
• Directs ongoing LDG QMS Forums with all stakeholders to keep updated on quality activities.
• Represents CORE on cross-functional Research and Development quality teams.
• Develops strategy to introduce and increase quality culture with LDG study teams.
• Prepares for ongoing Biannual Quality & Compliance Council updates with CORE Leadership Team and GMA Leadership (if applicable) on overall quality status for LDGs.

Qualifications:

Education:

• Bachelor's degree required.
• Master's degree in Public Health or other related discipline preferred (e.g. epidemiology, health administration, MBA or biological sciences).

Required Experience and Skills:

• 3-5 years relevant work experience in pharma or related industry, in a project or quality management related role. Certified project manager (e.g. CPM, PMP) with strong analytical and reporting skills preferred.
• Relevant experience in non-interventional/observational research and scientific background.
• Excellent communication and interpersonal skills and ability to collaborate with and influence a wide variety of stakeholders, with a capacity to work across cultures and hierarchical boundaries.
• Experience leading meetings and presenting to all levels of management (including Sr Management).
• Highly motivated, able to work independently and collaboratively, raising issues with recommendations for solutions.
• Familiarity with technology platforms (e.g. Trackwise, SharePoint, MS Teams, MS Planner, Veeva Vault).
• Ability to deal with ambiguity and can effectively cope with and embrace change.

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.

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

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.

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We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

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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:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R43464