We are currently looking for a Head of Quality Assurance. If you are seeking a rewarding and challenging career this could be the perfect opportunity for you. The position can be office based in Boston.
The successful candidate will be responsible for ensuring the streamlined operation of all aspects of Quality Assurance within the group. The job holder will be responsible for leading and managing Quality Assurance (QA) programs, activities, and staff to ensure compliance with global laws, regulations and applicable guidance.
- Ensure the Company is kept current with all new quality-related regulatory requirements, and provide guidance to senior and operational management on the implications of any new or updated requirements
- Ensure GxP awareness in the Company in interaction with functional departments
- Ensure quality (awareness) as part of the Companies business processes
- Implement and maintain a fit for purpose quality management system (QMS) ensuring that it has the appropriate level of rigor and controls to ensure compliance with applicable regulations and guidance
- Create and execute a plan for ensuring a state of inspection readiness and continuous improvement
- Create and execute a plan for QA services to be executed for third parties
- Provide feedback to department heads regarding audits, plans, findings, CAPAs, and issue resolution; provide suitable recommendations and facilitate ongoing quality improvements while maintaining compliance
- Lead and direct QA staff in the preparation of the quality components of global regulatory submissions
- Chair the Company Quality Assurance group or similar established body and report any substantial issues or concerns to Company management
- Lead, manage, mentor, develop and motivate the QA team in accordance with TECGroup Policies and local law
- Provide regular updates and recommendations to the Company's senior management team relative to quality compliance objectives.
- Master's or Bachelor's (or comparable) level degree in life sciences, or similar scientific discipline
- Minimum 7-10 years'+ senior quality systems leadership in a pharmaceutical company or CRO
- Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards including GCP, GCLP & GMP
- Previous experience working in a matrix organisation an advantage
- Experience in overseeing, participating and executing GMP/GLP/GCP audits and inspections; experience including external CRO, clinical/regulatory and document auditing desirable
- Demonstrated strategic thinking, business acumen and process assessment capability
- Strong interpersonal skills including the ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team
- Organizational agility (knowledgeable about how an organization works) and ability to apply that capability to lead change, deliver strong results and build the confidence and trust of stakeholders
- Ability to deal with complex, conflicting priorities and develop coherent, effective solutions
- Demonstrates significant judgement and decision-making capability with the ability to make difficult, but robust, rationalized and timely decisions balancing the totality of available data and risk
- Excellent written and verbal communication skills including excellent command of English
- Prepared to travel locally and internationally.