VICE PRESIDENT, QA/RA
BRIEF COMPANY PROFILE
Our client is a global medtech company headquartered in the Øresund region with several years of history developing, manufacturing and selling its innovative products globally to health care professionals.
Driven by a set of strong values, and with a promising pipeline of new groundbreaking products, our client offers a challenging position in an informal – though dedicated and dynamic – global organization with a high degree of interorganizational collaboration and focus on joint effort and commitment.
The Quality Assurance & Regulatory Affairs department
The QA/RA department is overall responsible for providing and ensuring regulatory and quality leadership, direction and compliance throughout the global organization contributing to product approval and superior product quality. Handling and ensuring proper risk management, upholding regulatory compliance and performing quality control and effective QMS process development is among the key objectives for the department, while exerting competent support and collaboration with internal and external stakeholders.
With the objective of further strengthening the Quality- and Regulatory platform – and as part of their current professionalization and growth journey – our client is looking to bring on board a Vice President QA/RA to take on the overall leadership of the area, while taking a seat in the top management team of the company.
In the position as Vice President QA/RA, you will be responsible for setting the direction for, and for driving, the global company QA/RA strategy, planning and implementation and thus building capabilities ensuring compliance to industry standards and regulations.
Leading an organization of +25 FTE’s, including middle managers for “RA”, “QA” and “QC” respectively – and as part of a well-functioning, dedicated and strongly aligned executive management team – strong leadership and management is of the essence, while the ability to contribute strategically and operationally is equally crucial to the success and expectations of the position in question – and the organization at large.
Consequently, the position calls for a senior, experienced, accomplished, ambitious, robust, driven and self-managing RA/QA professional with vast experience from building, driving and leading RA/QA organizations within a global environment – coupled with superior business understanding and sound stakeholder-, partnership-, political- and collaboration skills and capabilities.
Vice President, QA/RA
20-30 days per year
Responsibilities & Tasks:
Part of the executive management team of our client contributing to company strategy development, planning and execution.
Leading the global QA and RA strategy development, planning, and implementation – and setting the direction for future goals and ambitions.
Developing and implementing policies and processes to ensure ongoing compliance of regulatory requirements and standards.
Responsible for maintaining and improving the Quality Management System in accordance to MDR (2020), ISO 13485, Quality System Regulation (FDA) and other relevant national and international requirements.
Ensuring seamless collaboration with key partners.
Identifying and mitigating risks and developing alternative courses of action, including anticipation of regulators responses through scenario planning and development of contingency plans.
Anticipating quality and regulatory related obstacles, and emerging issues throughout the product lifecycle.
Ensuring that regulatory and quality input for follow-up to inspections and audits are provided.
Responsible for recall and recall communication processes.
Ensuring that adverse events are reported to regulatory agencies and internal stakeholders.
Ensuring adequate internal reporting on quality and environmental indicators, activities, results and non-conformities.
Managing, leading and mentoring the QA/RA organization, including ensuring smooth and efficient workflows and collaboration within and across among teams.
Key success criteria:
Successfully setting a clear internal direction and strategy, while ensuring strong alignment with the strategy and requirements of key partners.
Successfully building improved QA/RA muscle globally in the organization, including clear strategy definition and implementation for the QA/RA area.
Successfully delivering on QA-related KPI’s, including among others NCR/CAPA’s, QMS compliance, doc control, complaints, design control, validations etc.
Successfully delivering on RA-related KPI’s, including among others product life cycle submissions, notifications, variations, reviews, safety etc.
Successfully ensuring a high degree of compliance to relevant industry requirements and standards, including ensuring readiness for the new MDR legislation (2020).
Successfully driving a high-performance culture focused on joint effort and commitment acknowledging overall company success as essential to team- and personal success.
Successfully achieving operational excellence within QA/RA by ensuring that the right capabilities, structures, systems and processes are in place.
Relevant education – ideally at M.Sc. level or higher.
English – fluent (verbally and written).
Ideal experience and competencies:
+10 years of experience with Regulatory Management and/or Quality Management – ideally from the medical devices industry or alternatively the pharmaceutical industry – preferably from a global HQ function or alternatively in a regional setting.
+7 years of experience as a people manager building teams and organizations, including fostering strong and ambitious cultures and collaboration.
Experience in “charting the course” for a QA/RA function/team managing vision and purpose while demonstrating strategic agility.
Experience in developing and executing superior QA/RA strategies globally and across functions/teams.
Ideally experience from a larger production company in the life science industry, including operational experience (although with personal motivation and ambition towards strategic work and engagement).
Excellent understanding and experience from working with, and navigating within, strategic partnerships.
Excellent understanding of regulatory demands, including ISO-13485 and preferably in-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (FDA, ISO and MDD).
Proven track record of driving innovation and growth in an international setting responding to customer needs, while advancing new ways of thinking in the team.
Proven track record with problem solving – ideally including continuous improvements/LEAN/Kaizen experience.
Good working knowledge of IT tools and specifically Quality Management systems.
Motivation and inspiration
Is motivated by obtaining company and organization goals and ambitions – and acknowledges that personal goals are best achieved through company success. Inspires others, creates followership and encourages the achievement of set goals by promoting a sense of purpose. Provides inspiration for a positive work attitude and prompts a strong wish to succeed in the team.
Self-knowledge and development
Remains critical towards own performance and leadership and strives towards continuously improving capabilities, while being able to acknowledge own faults and mistakes with a view to remedy rather than explain away. Is motivated by developing one self and the company – and thrives within chaotic working environments in which the candidate obtains motivation from establishing structures and processes. Possess a self-deprecating sense of humor.
Leadership and responsibility
Displays strong leadership and takes ownership regarding strategy as well as execution. Makes sure employees and peers have a clear understanding of the direction of the tasks, takes action, organizes resources and directs others toward successful execution of tasks. Drives projects forward to reach pivotal objectives, makes things happen and follows through.
Relations and stakeholders
Is able to establish and maintain relations with people at all levels internally as well as externally and make people feel at ease. Achieves agreement by dealing with disagreements and potential conflicts with diplomatic skills. Develops and maintains networks and illustrates superior political and strategic acumen.
Possess excellent cross-cultural communication and presentation skills. Is to the point and communicates the central issues in a discussion in a clear, fluent and precise manner. Is able to keep the recipients' attention, is attentive to the needs of others when he/she speaks, and produces written material that is clear, fluent, precise and easy to understand.
Delegates responsibility to the relevant employees and allows them room for maneuver to explore own initiatives. Empowers people in order for them to carry out tasks efficiently.
Works systematically, organizes work and effort and is methodical in one's performance. Holds on to commenced tasks and projects and sees things through.
Coaching and support
Actively strives to improve skills and talent of the employees by giving positive and constructive feedback. Provides training and tasks with a view to challenging their skills and encourage development.
Results and goal orientation
Is proactive, result-oriented, self-driven and persistent. Establishes visible, achievable, and ambitious goals. Focuses on action, activities and results whilst being mindful of team members’ individual needs. Is able to continue working at a specific problem, viewpoint or action plan until a result has been achieved, or until it is determined that an alternative approach is needed.