Executive Director, Quality Assurance

About the position

The Executive Director of Global Clinical Supplies Quality is responsible for providing leadership to a team of Quality professionals assuring the reliable availability, quality and regulatory compliance of clinical supplies in support of the clinical development programs for the R D portfolio to enable the execution of all clinical trials (including more than 300 Phase I-IV clinical trials run inhouse, 400+ outsourced trials, 200+ IIS clinical trials and 200+ External Collaborations across 60+ countries) in accordance with worldwide regulations, company policies and standard operating procedures. The position will be instrumental in developing and utilizing an organization of skilled people managers and technical SMEs in close collaboration and partnership with Global Clinical Supply, Global Clinical Trial Operations, Translational Medicine, Global Regulatory Affairs & Clinical Safety and Quality functions enabling the R D portfolio. This position will require strong strategic and leadership skills to manage and solve problems for the diverse and fluid requirements of our complex clinical supply chain while also influencing outcomes and continuously improving the systems, tools and processes required to enable to supply chain.

Responsibilities

• Quality oversight of clinical supply chain activities (packaging, device assembly, labeling and distribution operations) for the internal network sites including West Point, Rahway, WAG & Haarlem as well as the global external network through leadership of a matrix organization of approximately 165 team members (~85 through direct reporting relationship and ~80 through dotted line reporting relationship).
• Management of the Global Clinical Complaints process as well as cross-divisional activities for significant quality events impacting the R D portfolio.
• Oversight of the enabling functions within Global Development Quality including forecasting and planning, process ownership for business systems and tools and digital innovation for Quality Operations activities.
• Oversight of the transition and team establishment of the clinical trial country release activities ensuring timely execution in support of the R D portfolio.
• Develop long-term strategic plans and translate into integrated operational team priorities and activities.
• Ensure measurable and sustainable results through effective resource allocation, cross-divisional partnerships and execution of innovative strategies to enhance the organization's performance.
• Drive a global and harmonized approach to clinical supplies GMP activities and influence strategic plans via networking and partnerships with key stakeholders.
• Inspire and oversee multiple teams, ensuring team leaders are effectively supporting and empowering their teams.
• Management of significant quality events via acting as the facilitator of the Pharmaceutical Quality Council/ Stock Recovery Committee and the owner for the Clinical Stock Quarantine / Recovery process.
• Overall accountability of the ownership and management of the Clinical Complaints process, via the Global Clinical Complaints team.
• Interact cross-functionally and cross-divisionally with senior management on a wide array of topics involving quality/regulatory matters of the most complex and business-critical nature and externally with regulatory inspectors and colleagues in industry.

Requirements

• A minimum of 10+ years of relevant experience working within the pharmaceutical industry or advanced Degree with 8+ years relevant experience.
• Experience interacting with regulatory officials and external auditing parties.
• Organizational design, development and deployment in relation to dynamic business drivers.
• Division-level credibility / influencing ability founded on sound technical knowledge and delivery of results.
• Demonstrated leadership, strategy development and deployment experience in a pharmaceutical environment.
• Experienced and strong people manager with proven track record of developing talent.
• Direct experience in managing significant quality events (e.g. recalls) of a complex and high-profile / potential high-impact nature.
• Proven track record of delivering tangible benefits from process improvement activities with a demonstrated knowledge of continuous improvement methodologies; ability to direct complex cross-functional initiatives.
• Strong compliance knowledge and understanding of regulatory agency regulations and requirements and interpretation and application re; GMPs to a R D environment.
• Strong scientific/ technical expertise in R D activities, coupled with the ability to interact with scientific subject matter experts as a technical peer on various product initiatives and issues.
• Possess deep clinical supplies process knowledge; demonstrated ability to facilitate training and learning with colleagues and apply knowledge to enhance the clinical supplies process.
• Demonstrated experience in quality risk management in the pharmaceutical industry.
• Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills.
• Strong demonstrated skills in communicating (oral and written) effectively with diverse individuals / groups.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days