QA Manager
Contract/Interim
Salary negotiable DOE
CDM Life Sciences are seeking a dynamic and experienced Quality Manager to join our clients team. In this critical role, you will be responsible for overseeing the quality assurance processes within our packaging operations, ensuring compliance with all regulatory requirements and maintaining the highest standards of quality across all packaging activities.
Key Responsibilities:
* Lead and manage the quality assurance team to ensure all clinical packaging operations meet or exceed industry standards and regulatory requirements.
* Ensure compliance with GMP (Good Manufacturing Practices), GDP (Good Distribution Practices), and all applicable regulations.
* Prepare for and manage internal and external audits, including regulatory inspections. Address any findings with corrective and preventive actions (CAPAs).
* Oversee the development, implementation, and continuous improvement of quality management systems (QMS) related to clinical packaging.
* Maintain accurate and up-to-date quality documentation, including SOPs, batch records, and validation reports.
* Develop and deliver quality-related training programs for staff to ensure adherence to quality standards.
* Identify potential risks in the packaging process and implement appropriate controls to mitigate them.
* Work closely with clients to address quality concerns and ensure that their packaging requirements are met with the highest standards.
Qualifications:
* Bachelor’s degree in a related field (e.g., Life Sciences, Pharmaceutical Sciences, Engineering).
* Minimum of 5 years of experience in quality assurance or quality management within the pharmaceutical or clinical packaging industry.
* Strong knowledge of GMP, GDP, and other relevant regulatory frameworks.
* Proven experience in leading and developing quality teams.
* Problem-Solving: Strong analytical skills with the ability to identify issues and implement effective solutions.
* Excellent verbal and written communication skills, with the ability to interact effectively with internal teams, regulatory bodies, and clients.
* Meticulous attention to detail with a commitment to maintaining the highest standards of quality