Head of Quality Assurance

TATAA is a fast-growing company with two decades of history and is preparing for global expansion backed by an investment firm. The company is comprised of a team of scientists providing laboratory services, products and training across a broad range of molecular analysis technologies including q/dPCR, NGS and proteomics. The company serves pharma, biotech and academic customers and is considered the leader in the field. This position offers an exciting opportunity to get involved early on in setting up TATAA for its next phase of growth.

ARBETSUPPGIFTER
TATAA is recruiting a passionate leader to be Head of Quality Assurance. The scope of this role encompasses leading and expanding a group that introduces and maintains GLP/GCLP and maintains and broadens, as considered strategic, companys current ISO accreditation, which is flexible SS-EN ISO/IEC 17025:2018 with a scope including relative and absolute quantification by qPCR. The QA team interacts closely with companys operational management.

Main Responsibilities
• Act as the primary contact for clients and regulatory inspections and as the site expert for regulatory guidelines and assist with the preparation and hosting of client audits and/or regulatory inspections.
• Plan and execute study-based inspections as required for compliance with GLP, GCLP, SOPs, bioanalytical method validation guidelines (FDA, EMA).
• Conduct periodic facility/system and process audits as required for compliance with GLPs, GCLPs and SOPs.
• Lead the GLP implementation effort with tasks including: overseeing hiring of key personnel, writing of SOPs, instrument validation and facilities protocols, implementing raw data storage and retention initiatives, and other duties as needed.
• Provide training to technical and professional staff on GLP/GCLP regulations.
• Lead ongoing process improvements to improve best practices.
• Instill and manage a culture of continuous improvement, quality, and productivity.
• Report all findings in writing from the audits and inspections to relevant personnel.
• Review audit responses and follow-up with principal investigators to ensure audit finding impacts are assessed and promptly communicated to test site facility management; monitor the progress, appropriateness, and correct implementation of corrective measures.
• Prepare, review, and improve QA procedures.
• Review and approve other company procedures.
• Collaborate with laboratory technicians, principal investigators, and test site facility management.
• Act as the contact person for quality questions from the organization.
• Maintain current knowledge of standard requirements according to GLP, GCLP, ISO17025 and other relevant guidelines related to the business process.

KVALIFIKATIONER
Requirements & Personal skills - Skallkrav
Requirements:
• M.Sc. or B. Sc., in Life Sciences or a Quality-oriented education
• At least 5 years of experience in a GLP/GCLP regulated environment with at least 2 years of demonstrated leadership experience
• Advanced working knowledge of current regulatory guidelines including GLP, GCLP and ISO 17025
• Experience with LIMS and QMS systems
• Experience working in the CRO/Pharma industry is highly preferred.

Personal skills:
• Excellent communication in English and Swedish and interpersonal skills with the ability to influence others with impact
• Outstanding experience with client satisfaction and problem-solving solutions
• Team player, able to collaborate efficiently with other managers and department heads
• Relationship-builder
• Ambitious and driven

ÖVRIGT
Start date: Upon agreement

We welcome you application!
Both CV and cover letter are required.

We will apply an ongoing recruitment process, which means that the position can be filled before the application deadline.

Please note that we kindly decline any offers from recruitment or staffing agencies regarding this recruitment.