Associate Director, Planning & Scheduling

Job Description

Associate Director, Clinical Supply Operations (P4)

Position Description

The Associate Director, Clinical Supply Operations (CSO) is responsible to support our clinical supply packaging, distribution, and label printing operations at the Rahway, NJ site.   This pivotal role will collaborate with a diverse range of stakeholders, subject matter experts, and customers both within and outside of Global Clinical Supply (GCS). Your leadership will be instrumental in driving innovative initiatives, ensuring operational efficiency, and maintaining compliance, all while supporting our commitment to business continuity.

Key responsibilities of the Associate Director, Clinical Supply Operations include:

• Supporting the operational efficiencies and initiatives of clinical supply operations; including packaging, distribution, and label print operations in Rahway, NJ.

• Assist in ensuring operational readiness for the expanding landscape of on-site clinical capabilities.

• Lead efforts to sustain inspection readiness by implementing standardized workstreams.

• Ensure efficient and compliant processes by taking ownership of the development and enhancement of standard operating procedures (SOPs) at both local and global levels.

• Effectively collaborate with other CSO nodes, optimizing interactions with partner groups such as Packaging, Label Room, Operations Planning, Quality, Master Planning, Bulk Manufacturing, and Analytical (for cleaning, swabbing, and investigations) to support business continuity and portfolio requirements. 

• Establish strong partnerships with quality teams to ensure agility and responsiveness in meeting portfolio demands.

• Adaptively manage responsibilities and activities across CSO workstreams to support business objectives, leveraging Tier processes as appropriate.

• Collaborate with on-site upstream drug product manufacturing to implement integrated operations within clinical supply.

• Identify opportunities for innovation and process improvement, supporting necessary changes to enhance operational effectiveness.

Position Qualifications:

Education Minimum Requirement:  Bachelor's Degree in Engineering, Supply Chain, Business, or related field.

Required Experience and Skills:

• Minimum of 7-10 years of experience in production operations, technical project management, engineering, or management roles within the pharmaceutical industry, with a solid understanding of clinical supply needs, Good Manufacturing Practices (GMP), packaging, and distribution operations.

• Strong understanding of current Good Manufacturing Practices (cGMP), including compliance with FDA and EMEA regulations.

• Proven experience in leading teams and managing complex projects effectively.

• Demonstrated ability to lead cross-functional teams through all phases of project planning and execution.

• Experience in collaborating with vendors and external partners to achieve project objectives.

• Ability to work effectively across organizational boundaries and build strong collaborative relationships with diverse groups.

• Strong skills in stakeholder management and the ability to build and maintain cross-functional networks.

• Excellent communication skills, with the ability to engage effectively with various global professional levels and external stakeholders.

• Demonstrated ability to prioritize tasks and manage multiple responsibilities efficiently.

• Proficient in the Microsoft Office Suite and other relevant applications.

Preferred Experience and Skills:

• Direct experience in pharmaceutical packaging and distribution operations is highly valued.

• Experience with cold chain clinical supply, including packaging and distribution operations.

• Knowledge of SAP systems and their application in supply chain management.

• Possession of Six Sigma certification (e.g., Green Belt or Black Belt).

• A demonstrated dedication to solving complex problems through innovative thinking and imaginative strategies.

• Understanding of scheduling and capacity modeling to ensure optimal resource allocation.

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