Senior Operations QA Manager – Labeling and Distribution (onsite position)

SUMMARY/JOB PURPOSE:

The Senior Operations QA Manager - Labeling and Distribution is accountable for executing assigned tasks and applying Quality tools and metrics to drive continuous improvement across systems and projects. This individual is responsible for the end-to-end Quality oversight of storage and distribution of clinical and commercial products, raw materials, Registered Starting Materials, GMP intermediates, etc; Quality oversight of Exelixis Third-Party Logistics (3PL) network, identifying, resolving, mitigating issues and risks, and escalating. Manages Temperature Excursions; executes Clinical and Commercial Artwork and Labelling. Partners within QA and cross-functionally.

This position is the single point of contact (SPOC) and actively partners with both internal and external stakeholders. Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality for Exelixis business stakeholders, represents QA in an outwardly and business-facing capacity, in strategic and decision forums, and triages communication between Exelixis business functions internally or externally and QA, to provide and ensure delivery on company core goals and pipeline deliverables. This position has influence across several disciplines to deliver a clear strategy to maintain and improve TE reporting and product distribution of product.

It is imperative for the Senior Manager to forge strong relationships with 3PL to maintain performance and continuous improvement. Directs partnerships and collaborations. Demonstrates a high level of independent quality judgment and acumen.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Maintain end-to-end quality standard defining the framework for GxP warehousing and transportation management system, using a lifecycle approach, covering clinical through commercial product, align with commercial business drivers and process development capabilities.

• QA Partner for the Exelixis 3PL network, including- Release of goods for shipment, management of temperature monitoring/excursions (TE), and audit support.

• Drive process for returned goods.

• Identify and mitigate risk associated with logistics and warehouse storage of supply chain, escalate issues as appropriate.

• Define and oversee tracking and trending of 3PL quality metrics or supported systems.

• Interpret and apply applicable Health Authority regulations and guidance across the 3PL network and Exelixis’ Quality System. Review new regulations/guidance to assure compliance.

• Communicate TE reporting/requirements to stakeholders; timely review/approve TE reports for accuracy/completeness; provide feedback/guidance to stakeholders on TE reports.

• Execute Clinical and Commercial Artwork and Labelling (label development, generation, review, approval), including vendor oversight; resolve quality issues.

• Deliver timely on company core objectives, per supply plan, and drive for results.

• Partner with QA and cross-functional teams (Production and Supply Chain (PSC), Clinical Development/Operations, RA, etc.)

• including

• Provide technical expertise and leadership, beyond Quality’s sphere of influence.

• Support processes that ensure transition from clinical to commercial, new product introductions, and flexibility across the network.

• Use broad expertise or unique knowledge and skills to drive company objectives and principles and achieve goals in creative and effective ways.

• Implement innovative and feasible solutions to complex problems.

• Strong influencer and driver to completion.

• Strong collaborator and negotiator toward effective solutions.

• Excellent verbal and written communication and presentation skills.

• Make clear recommendations, communicate, escalate, and drive timely and effectively.

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and a minimum of 9 years of related experience; or,

• MS/MA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and a minimum of 7 years of related experience; or,

• Equivalent combination of education/training and experience

Experience/The Ideal for Successful Entry into Job:

• Minimum of 9 years experience in bi