Job Description

Country Clinical Quality Manager South East Asia

• Opportunity to join a leading global biopharma company
• Exciting chance to work with passionate and collaborative teams
• Be at the centre of innovation and excellence in execution.

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.It is critical that, for all company sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The Country Clinical Quality Manager (CCQM) position has a significant impact in achieving those objectives. Under the guidance of the Regional Director, Clinical Quality Management (RCQM), the CCQM oversees all Clinical Quality Management (CQM) activities in Singapore & Malaysia Market. 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.Primary ResponsibilitiesRegulations & Processes:

• Local expert for ICH-GCP and local regulations. In close collaboration with local country operations management, manages the local network of owners and 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) and Work Instructions.

• Local expert for any quality-related local processes. Identifies process gaps and opportunities for process improvement and properly escalates to RCQM or Global Process Owners.

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

Training:

• Local training point of contact and the liaison between local country operations and Learning & Development. In close cooperation with local country operations management, identifies and coordinates local training needs.

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), the Quality Control Visits as well as any other QC Checks.

• In mutual agreement with local country operations management and the RCQM, performs QC activities 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, develops local action plan

Audits & Inspections:

• Primary local point of contact for MRL Quality Assurance and Regulatory Agencies.

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

• In cooperation with local country operations and headquarters, performs root-cause analysis for audit observations and 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 and develops local action plan.

Quality / Compliance / Privacy Issue Escalation:

• Communicates/escalates quality/compliance issues to local country operations management and RCQM.

• Escalates significant quality/compliance issues and supports investigations.

• Serves as local POC or supports local POC in case of escalations or reporting of Privacy Incidents, if applicable.

• 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.

Supplier Qualification:

• Leads local supplier qualifications and re-qualifications of locally selected suppliers and supports solving of quality issues with locally selected suppliers.

• Supports the Quality Management System assessment for local supplier qualifications and re-qualifications.

MRL Compliance & Privacy Steward:

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

• Communicates compliance/privacy concerns to local legal/compliance/privacy department and/or MRL Compliance and Global Privacy Office.

What should you have:Qualifications:

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

Experience:

• A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments. Experience in Country Operations preferred.

• Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research related regulations.

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

• Demonstrated experience in leading cross-functional teams. Hands on in Clinical Quality Management including Quality Control Activities, Process Management & Improvement.

• Strong track record in managing audits and inspections as well as experienced in coordinating and delivering training sessions.

Skills:

• Great oral and written communication and leadership skills in an international environment.

• Excellent project management, organizational and prioritization skills.

• Great teamwork skills, including conflict resolution expertise and discretion.

Able to analyze, interpret, and solve complex problems. Can 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.

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\xe2\x80\x99s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Current Employees applyCurrent Contingent Workers applySearch 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: RegularRelocation: No relocationVISA Sponsorship:Travel Requirements:Flexible Work Arrangements: HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date: 07/8/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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