Associate Director, Clinical Supplies Quality Assurance - Hybrid

Job Description

The Associate Director, Clinical Supplies Quality, is a dynamic position that will have responsibility for support of US quality operations and disposition, global distribution planning and management, and requires organizational skills and leadership to work effectively and proactively on global functional teams.

Primary Responsibilities:

• Responsible for operational and technical support of Clinical Supply Chain for clinical development programs for the company's portfolio, specifically in terms of assuring the reliable availability, quality and regulatory compliance of clinical supplies produced

• Development and execution of Quality and key stakeholder strategies, improvement initiatives in line with business drivers and objectives whilst streamlining processes and procedures and leveraging technology.

• Closely collaborate with appropriate business/operations areas to ensure that effective and robust Quality systems and processes are in place.

• Ensuring the reliability of clinical supplies availability for our Company's clinical trials via development of business processes, tools, and data analytics, with the associated potential for high impact to the development portfolio.

• Provision of in-depth technical / quality expertise regarding interpretation of data, development of metrics, identification of trends and/or potential compliance gaps and proactively leading the resolution.

• Global Stewardship for process development and improvement, providing expertise and guidance, and ensuring consistent application of functionality for the Quality teams supporting the end-to-end Clinical Supply Chain.

• Process ownership, development and management of high profile and high impact significant quality events related to clinical supplies including fact-finding, investigation, coordination of clinical quarantine and recovery actions involving cross-functional interactions with diverse groups at senior levels.

• Coaching, mentoring, and developing team members supporting their personal development and also colleagues in areas of expertise.

Education Minimum Requirements: 

• Bachelor’s degree in engineering, Biology, Chemistry, or related field.

• A minimum of 5+ years of relevant experience working within the pharmaceutical industry.

Preferred Experience and Skills:

• Strong comprehension of regulatory agency regulations and requirements coupled with proficiency in interpreting and applying current Good Manufacturing Practices (cGMPs) to our Research & Development environment.

• Strong technical expertise in our Research & Development activities specifically related to clinical supplies, Medical Device/Combination Products, design, and implementation of new technologies etc.

• Demonstrated operational management experience, including capacity planning, forecasting, and scheduling.

• Demonstrated knowledge of continuous improvement and project management methodologies; ability to lead matrix teams and direct complex cross-functional initiatives, recognize improvement opportunities, develop appropriate solutions, and follow through on implementation.

• Demonstrated leadership, including strategy development / deployment and experience with tangible delivered benefits.

• Demonstrated experience in quality risk management in the pharmaceutical industry.

• Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills.

• Demonstrated excellence of skill in communicating (oral and written) effectively with diverse individuals/ groups at all levels.

• Computer skills; knowledge and competency in SAP, ERP/MES, Trackwise, PowerPoint, Excel, and Word.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual