Quality Management Systems and Compliance Manager

Proclinical's client is a well-established biotechnology company that is seeking a Quality Management Systems and Compliance Manager to be based in Cambridge on a permanent basis.

As the Quality Management Systems and Compliance Manager you'll drive the development and implementation of the company's quality management systems for the new Cambridge site, so as to ensure operational excellence is maintained across all elements of product development, distribution, supply chain and on market support. You will work closely with functional departments and key stakeholders to strengthen and improve quality system and drive efficient and effective compliance to regulatory requirements.

Job Responsibilities:

• Establish and maintain a QMS certified to ISO 13485:2016 at the new company EMEA headquarters
• Actively manage the deployment of ISO 13485:2016 transition Quality Master Plan for the company's Cambridge site in collaboration with the global QMS and Compliance team
• In collaboration with key stakeholders, contribute to implement QMS strategy in EU for compliance to the impending IVDR regulation for company products sold in EU while maintaining compliance with IVDD, laboratory standards and other applicable regulations
• Ensure the quality systems meet regulatory, customer, corporate, or internal requirements and any other related requirement within the Quality Management System.
• Develop the procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for regulatory bodies inspection or/and ISO third party audits.
• Manage and/or perform internal and external compliance audits/ inspections as well as participate in management of corrective action program (i.e., audits, inspection, field corrections) to ensure timely follow-up, completion and documentation of corrective actions
• Works closely with cross-functional teams in overseeing and providing regulatory guidance on development activities.
• Manage processes within the QMS and serves as a Quality champion towards quality improvement initiatives
• Works closely with teams a cross-functional departmental areas; including Regulatory Affairs, Commercial operations including technical support, installation and servicing
• Identify Quality and Compliance risk issues affecting the company or its external customers in need of compliance support through the monitoring of internal and external audits
• Provide support ensuring external audit readiness and during external audits and corporate internal audits
• Ensures the corrections of findings, risks and recommendations are promptly and thoroughly incorporated into the quality systems
• Identifies and shares "Best Practices"
• Participate in investigations of quality system issues and drives CAPA implementation to ensure CAPA findings, risks, recommendations, and outcomes are appropriate and are clearly documented and communicated
• Trends, analyses, and reports on quality data to improve product and process Quality; develop recommendations based on data analyses
• All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Skills and Requirements:

• BSc or MSc (or equivalent) in science, engineering or related field or equivalent experience
• Excellent understanding of medical device QMS and ISO 13485:2016 requirements
• Significant experience gained within IVD / medical device / biotech / pharma industries of implementing QMS procedures and processes
• Understanding of IVD/medical terminology and familiarity with clinical terms and disease states
• Knowledge of global IVD medical device regulations, requirements and standards such ISO13485:2016, 21 CFR Parts 803, 806, and 820, ISO14971,) European Medical Device Directives MDD/IVDD/AIMD, MDR, IVDR, MDSAP, Canadian Medical Devices Regulation (SOR/98-282), CFDA IVD Regulations, Japanese MHLW Ordinance 169
• Process improvement and procedure writing expertise
• Experience of conducting audits
• Demonstrated project management experience in leading cross-functional teams
• Detail oriented, well organized and able to work independently and in teams.
• Good communication skills both verbal and written
• Flexible, able to adapt quickly to change in a fast-paced environment
• Solid problem-solving skills
• Fully proficient with Microsoft Office
• Willing to travel as required (approx. 20%) including international travel

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Chidozie Orji on +44 207 4400 671 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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