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Director, Clinical Quality Assurance, AREA
4 months ago
Director, Clinical Quality Assurance, AREA - Europe
- Reporting into the Global Director of RDQA, Clinical Quality Assurance AREA.
- Leading a team of 5 (AD’s & Senior Managers)
- Competitive salary, LTI’s, Car allowance, Bonus and benefits.
Objective
Director, Clinical Quality Assurance, AREA - Europe is responsible for the management of a Clinical QA team which provides quality support to R&D affiliates across Europe in the conduct of interventional clinical trials and investigations, to ensure AbbVie’s standards are maintained, and first pass approvals are achieved for our therapies in clinical development programs. With a focus on pro-active quality this role supports Clinical Development regionally and globally to ensure; quality excellence, data integrity, the realization of R&D goals and objectives for submission of new therapies, adherence to the One AbbVie Quality System and execution of RDQA Quality System Excellence (CAPA, Change Management, Quality Risk Management, Documentation Standards).
This role provides expert technical quality support and consultation to R&D colleagues and Development Operations business partners and is the primary CQA contact for Regulatory Agency GCP country sponsor and site inspections in 35+ countries in Europe, as well as for UK MIA IMP GMP inspections. This role will act as lead for other European regulatory inspections with Clinical topics in scope.
Key responsibilities
- Lead a team to drive a continuous state of compliance with global and regional guidance and regulations, AbbVie policies and procedures and regulatory preparedness for Clinical trial and Clinical investigation inspections to deliver business results while positioning AbbVie for future success.
- Consistently demonstrate AbbVie’s Ways of Working and Leadership Attributes including a collaborative mindset and people leadership. Effectively manage performance inclusively and equitably; provide timely feedback, appropriately reward and recognize valuable achievement, develop talent and create a succession pipeline. Create a learning environment, embrace the ideas of others, and manage innovation to reality.
- Establish high expectations and goals to ensure organisational success and lead staff to meet or exceed those expectations. Encourage a culture of open and honest communication where all are encouraged to express their views, offer suggestions and experiment for improvement.
- Deliver innovative quality strategies and solutions through influence and collaboration with business partners at all levels, including senior management, to support effective and timely solutions/responses to compliance issues/questions including audit/inspection findings impacting Development operations. Responsible for serious breach reportability decisions in the assigned countries and region.
- Develop and implement an ongoing initiatives in the region to assess potential quality risks, including data integrity issues and drive identification, mitigation and prevention. Identifies/facilitates key quality improvements and innovation. Drives vision of continuous state of regulatory preparedness.
- Support Global business process owners directly to ensure quality is integrated at all stages of process development.
- Active leader in the conduct of GCP / Clinical investigations of device inspections, providing strategy, expert guidance and support to enable successful inspections and high quality CAPA.
Qualifications
Qualifications & Experience
- Bachelor's degree required preferably in Biology, Nursing, Pharmacy, or other medical science degree combined with equivalent technical experience. Masters/PhD is desirable but not essential.
- Experience in any combination of Clinical Research, Quality Assurance or Compliance roles or comparable experiences, including progressive leadership positions.
- Proven leadership skills with direct reporting and matrixed environments and ability to build teams.
- Ability to evaluate the quality of affiliate clinical operations, make judgments and assessments of performance under regulatory inspections.
- Ability to influence with recommendations for prevention and/or remediation strategies for potential gaps, often under a number of constraints and with a clear understanding of their future impact.
- Agile and able to respond rapidly to unplanned events, changing needs of development programs as well as changing regulatory requirements and expectations.
- Strong analytical skills and the ability to organise work in a logical, thorough, and succinct manner.
- Ability to work at an experienced operations level and demonstrate effective leadership and interaction with RDQA business partners (at all levels) and represents AbbVie with external partners.
- Ability to formulate decisions and approaches in the complex, matrix world of Clinical Research.
- Steps up and takes leadership to own toughest challenges, and in collaboration with stakeholders persisting to achieve the right results for the organization. Motivates and can influence others, including those over whom they have no direct authority.
- Professional, accountable, high energy and collaborative team player.
- Extensive knowledge of quality standards, worldwide regulatory requirements and industry best practices relating to Clinical trials and investigations. Strong understanding of regional and local regulatory requirements.
Additional Information
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
