Manager, Quality Assurance

KCR Placement is a full-service functional sourcing and recruitment provider. We specialize in high-speed and high-quality talent sourcing for the CRO, Pharmaceutical, Biotech and Medical Device industries across Europe. 
Our employees are KCR Placement's most crucial asset. We commit to placing our candidates at the center of all we do and prepare them for long-term career development and success with competitive benefits and vibrant work environment. 
The KCR Placement team is supported by a specialized referral network of expert professionals and is dedicated to providing sourcing services and client support from job requisition to job offer. 

On behalf of our partner, one of the global leaders in clinical research, we are seeking an experienced Manager, Quality Assurance to join their innovative and collaborative team.

The Q&C Manager role will be responsible for overseeing client site audit process, including line management of the external site audit team. Roles and responsibilities will include, but not be limited to oversight of incoming site audit workload, supporting project teams and the auditors with the finding responses, RCA and CAPA development, overseeing the quality of records in the QMS and leading CAPA development for any critical issues.

This role will work closely with company's clinical operations teams to support process improvements and trending of external site audit data. The right candidate will have previous experience with CAPA development, strong root cause analysis skills and some knowledge of site audit processes. Previous line management experience is preferable, but not essential.

As a Manager Quality Assurance you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

Manager, Quality Assurance

Location: Home or Office - Bulgaria, Poland, South Africa

Duties and Responsibilities:

• Developing and implementing quality assurance strategies and processes to support clinical trial activities;
• Conducting quality assessments and audits to ensure compliance with regulatory standards and guidelines;
• Collaborating with project teams to identify and address quality issues and implement corrective actions as needed;
• Providing guidance and support to staff regarding quality assurance policies, procedures, and best practices;
• Contributing to the development and maintenance of quality management systems and documentation.

Qualifications, Skills & Experience:

• Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred;
• Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry;
• Knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations);
• Strong analytical and problem-solving skills, with the ability to identify and resolve quality issues effectively;
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.

Benefits:

• Various annual leave entitlements;
• A range of health insurance offerings to suit you and your family’s needs;
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead;
• Global Employee Assistance Program;
• Life assurance;
• Country-specific flexible benefits, including options like gym membership discounts, childcare vouchers, and more.

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KCR is an equal opportunity employer. In line with our motto, ‘We see human behind every number,’ KCR is committed to fostering an inclusive culture and maintaining a diverse, safe, and respectful working environment with equitable treatment for all.

We are committed to non-discriminatory practices and provide an equal opportunity for all qualified employees and job applicants within all employment sectors. We believe that in developing a desirable culture of belonging in which diverse perspectives and voices are welcomed and heard, the full potential of employees can be achieved.