Job Description

Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

We are looking for a Country Clinical Quality Manager to support the quality of clinical trials conducted by the Clinical Trials Operations in UK and Ireland.

It is critical that, for all sponsored clinical trials, patient safety, high quality data and compliance with regulations are granted. The CCQM position has a significant impact in achieving those objectives.

Under the guidance of the Director, Country Clinical Quality Management Lead (CCQM-L), the CCQM oversees all CQM activities in the respective country/cluster. The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, inspections as well as Quality Control and local training activities.

Regulations & Processes:

Local expert for ICH-GCP and local regulations (incl. impact assessment of new/updated local regulations on local processes).

In close collaboration with local country operations management, manages the local network of owners / Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local Standard Operating Procedures (SOPs) / Work Instructions (WIs).

Local expert for any quality-related local processes.

Identifies process gaps / opportunities for process improvement and properly escalates to CCQM-L and/or Global Process Owners (if necessary).

Leads continuous improvements activities at the country level and supports or co-leads continuous improvements activities at the global/regional level.

Training:

Local training point of contact and the liaison between local country operations and Learning & Development (L&D).

In close cooperation with local country operations management, identifies / coordinates local training needs. * Supports local trainings (as needed).

Quality Control (QC) Activities:

In conjunction with the local country operations management, coordinates and oversees all QC activities. This includes to ensure a proper execution of the In-house Quality Control Plan (IHQCP), the Quality Control Visits (QCVs) as well as any other QC Checks.

In mutual agreement with local country operations management and the CCQM-L, performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request.

On a regular basis and in collaboration with local country operations, identifies local trends, performs root-cause-analysis (if necessary), develops local action plan (incl. sharing of results and training of local country operations, if required).

Audits & Inspections:

Primary point of contact for our Research Laboratories Quality Assurance and Regulatory Agencies.

Manages and supports activities during the preparation / ongoing / follow-up phase of an audit or inspection.

In cooperation with local country operations and/or headquarters, performs root-cause-analysis for audit observations/inspection findings, manages and tracks the Corrective and Preventive Actions (CAPAs) and coordinates/facilitates the responses to audit/inspection reports.

On a regular basis and in collaboration with local country operations, identifies local trends, performs root-cause-analysis (if necessary) and develops local action plan (incl. sharing of results and training of local country operations, if required).

Quality / Compliance Issue Escalation:

Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management and CCQM-L.

If indicated, escalates significant quality/compliance issues per company process and supports investigations (fact finding, root-cause-analysis) as well as the reporting of "\xcb\x9cSerious Breaches\', if applicable.

Local POC for escalations of GCP and Privacy Breaches that occurred in clinical trials, or supports local POC for escalations of GCP and Privacy Breaches, if necessary.

Clinical Supplies GCP Investigations:

Evaluates trends on Clinical Supply GCP Inquiries and incorrect management of clinical supplies.

Coordinates GCP Investigations of trends related to Clinical Supply GCP Inquiries and incorrect management of clinical supplies (if necessary).

Vendor Qualification:

Leads local vendor qualifications and re-qualifications of locally selected GCTO vendors and supports solving of quality issues with locally selected vendors.

Supports the Quality Management System (QMS) assessment for global and local vendor qualifications and re-qualifications.

Our Research Laboratories Compliance Steward:

Supports implementation of divisional compliance initiatives and reporting at the local level.

Communicates compliance concerns to local legal/compliance department and/or our research laboratories Compliance.

Education:

Bachelor\'s Degree or equivalent in relevant health care area.

Skills:

Superior oral and written communication and people management skills in an international environment.

Excellent project management and organizational skills.

Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.

Ability to analyze, interpret, and solve complex problems.

Ability to think strategically, objectively and with creativity and innovation.

Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.

Experience:

Extensive relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments.

Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.

Demonstrated experience leading cross-functional teams of business professionals.

Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.

Solid experience in managing audits and inspections.

Solid experience in coordinating and delivering training sessions.

Current Employees apply

Current Contingent Workers apply

Search Firm Representatives Please Read Carefully
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.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship:

Travel Requirements: 25%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Merck Sharp & Dohme