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Country Clinical Quality Manager (CCQM) - Istanbul

Employer
Syneos Health
Location
Istanbul, Turkey
Salary
Competitive
Start date
18 May 2023
Closing date
6 Jun 2023

Job Details

Description

Country Clinical Quality Manager (CCQM) - Sponsor Dedicated
Home-based in Istanbul - Office visits 1 - 2 times per week


Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Why Syneos Health
  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

Job responsibilities

Under the guidance of the RCQM, 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:
o Local expert for ICH-GCP and local regulations (incl. impact assessment of new/updated
local regulations on local processes).
o 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).
o Local expert for any quality-related local processes.
o Identifies process gaps / opportunities for process improvement and properly escalates
to RCQM and/or headquarters (if necessary).
o Leads continuous improvements activities at the country level and supports

Training:
o Local training point of contact and the liaison between local country operations and the sponsor.
o In close cooperation with local country operations management, identifies local training
needs and initiates local training activities.
o Supports onboarding of local country operations personnel (quality-related topics).

Audits & Inspections:
o Primary point of contact for MRL Quality Assurance and Regulatory Agencies.
o Manages and supports activities during the preparation / ongoing / follow-up phase of
an audit or inspection.
o In cooperation with local country operations and/or headquarters, performs root-causeanalysis
for audit observations/inspection findings, manages and tracks the Corrective
and Preventive Actions (CAPAs) and coordinates/facilitates the responses to
audit/inspection reports.

Quality / Compliance Issue Escalation:
o Communicates/escalates quality/compliance issues (incl. any potential trends) to local
country operations management and RCQM.
o If indicated, escalates quality/compliance issues to MRL Quality Assurance and/or MRL
Compliance.
o Local POC for escalations of Privacy Breaches that occurred in clinical trials, or supports
local POC for escalations of Privacy Breaches, if necessary.
o MRL Compliance Steward (if applicable).

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

Vendor Qualification:
o Leads local vendor qualifications of locally selected GCTO vendors and supports solving
of quality issues with locally selected vendors.
o Supports the Quality Management System (QMS)

Qualifications

o Bachelor's Degree or equivalent in relevant health care area.
o 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. Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.
o Demonstrated experience leading cross-functional teams of business professionals.
o Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
o Ideally, experience in managing audits and inspections.
o Ideally, experience in coordinating and delivering training sessions.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

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