Practice Area Lead Compliance & Remediation

Summary:

The Practice Area Lead (PAL) provides a broad range of Quality Management and Compliance (QMC) leadership and consulting. Responsible for leading operational tasks including management of large client projects. Supports with the professional and organizational management, development and implementation of QMC Value Delivery Centre (VDC) strategies.

Responsibilities:

• Responsible for driving major new QMC programs in close collaboration with client partners and Practice Area Lead, including responsibility for implementation and continuous improvement of budget, KPls and other project management tasks.

• Thought leadership in relevant technical areas of QMC specialism.

• Develop and maintain client relationships and highlight opportunities for increased service.

• Communicate effectively with clients and Health Authorities.

• Responsible for the planning and execution of client projects in accordance with KPls. Leadership and strategic guidance of project teams with colleagues and qualified external partners.

• Provide QMC Strategy advice to a variety of client programs and projects. Active participation in staffing proposals and decisions for projects.

• Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues. As appropriate, shape future policies through thought leadership and participation in external bodies.

• Support the Practice Area Lead in designing, communicating, implementing and optimizing the Practice Area strategy. Representation of departmental interests towards the Practice Area Lead and Head of Value Delivery Centre QMC.

• Processes within the Practice Area.

• Comply with, maintain and take accountability for optimizing internal processes.

• Creation of a motivational working environment. Technical support and coaching of colleagues.

• Formation of the leadership culture within the department in close cooperation with the Practice Area Lead

• Leadership for acquisition of new clients/projects (proposal coordination, participation in bid defense meetings)

• Lead Value Delivery Centre commercial, marketing and business development activities including proposal input & management. Present seminars and lectures for colleagues, clients and professional audiences

• Oversee project team to ensure delivery to budget and manage resolution of any invoicing queries.

• In agreement with Head of Value Delivery Centre QMC providing on-site QMC support to PharmaLex clients.

• The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area

• Lead/Head of QMC.

Education:

• University degree in Life Science.

Experience:

• 20+ years' pharma industry experience.

• Extensive professional experience in industry or area of responsibility

• Good network across industry and associations

• In-depth understanding of pharmaceutical industry market trends regarding own technical area of expertise

• Complementary knowledge and expertise including financial & business acumen

• Solution focus driving resolution of comex problems.

Skills and Knowledge:

• Leadership and critique to drive definition of Global Consulting Service's (GCS) strategic goals as well as strategic goals of partnerships with clients (e.g. contribution to RfP responses for large outsourcing projects); ability to balance client requests and company interests.

• Thought leader when defining ways of working across the business.

• Ability to adjust rapidly to new, unknown, challenging situations and coach others through the change; full discretion to drive strategy and take action consistent with operating policies.

• Drives extensive business process reengineering activities and provides consultation related to change management. Proactively leads on up/cross selling opportunities. Ability to analyze and solve problems and to develop pragmatic solutions at a higher level (e.g. company level).

• Extensive experience and proven strength in leading, mentoring, managing and motivation of staff.

• Ability to lead large international and/or comex project teams, distribute work equally and according to team member's strengths as well as to achieve commitment according to project milestones, convincing others in difficult change management situations.

• Ability to manage client relationships at all levels including C-suite, ability to convey strategic goals of collaboration.