Exelixis
Senior Operations QA Manager - Labeling and Distribution (onsite position)
Exelixis, Alameda, California, United States, 94501
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.)
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 biotech, pharmaceutical, or related industry
Demonstrated knowledge of GxP, Health Authority Regulations, Quality Systems, and technical expertise in warehousing/storage and transportation/shipping processes and product quality decision-making.
Knowledge of biologics and chemical products preferred.
International/global experience preferred.
Experience with participation in regulatory inspections and audits, presenting or defending departmental systems and decisions.
Understand FDA, EU/ROW regulatory requirements and guidelines related to storage and shipping validation expectations.
Knowledge/Skills:Deep knowledge and understanding of clinical and commercial processes, global regulatory requirements, and GxP regulations.
Demonstrated knowledge and skills in driving company objectives and principles, achieving goals with measurable impact and outcome.
Demonstrated ability to apply a risk-based approach. Excellent written, verbal, and presentation communication skills and can translate complex concepts across all levels of the organization.
Excellent attention to detail, comfortable with ambiguity and complexity.
Excellent collaborator demonstrated ability to lead through change and identify opportunities resulting in positive business outcomes.
Excellent organizational agility and demonstrates obtaining results while strengthening internal and external relationships.
Able to influence decision-makers, utilizes sound problem-solving skills to recommend feasible options, and implements effective solutions.
Demonstrates strong time management and organizational ability to analyze and improve processes and consistently produce high-quality work.
Manages objective setting and balances commitments to prioritize and complete activities within established timelines and works well under tight timelines with the right-first-time results.
Withholds judgment to engage teams in addressing conflict positively by seeking diverse views and identifying options to achieve an equitable solution.
Models team spirit, culture, and ethics and drives across cross-functional teams to meet company objectives.
JOB COMPLEXITY:This role is critical to the success of the clinical and commercial programs and requires continuous communication to maintain alignment across the organization.
This role requires managing multiple competing priorities and the ability to evaluate data to detect weak signals, blind spots, and escalate cumulative risks.
WORKING CONDITIONS:This is an onsite position.Travel as required.
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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.)
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 biotech, pharmaceutical, or related industry
Demonstrated knowledge of GxP, Health Authority Regulations, Quality Systems, and technical expertise in warehousing/storage and transportation/shipping processes and product quality decision-making.
Knowledge of biologics and chemical products preferred.
International/global experience preferred.
Experience with participation in regulatory inspections and audits, presenting or defending departmental systems and decisions.
Understand FDA, EU/ROW regulatory requirements and guidelines related to storage and shipping validation expectations.
Knowledge/Skills:Deep knowledge and understanding of clinical and commercial processes, global regulatory requirements, and GxP regulations.
Demonstrated knowledge and skills in driving company objectives and principles, achieving goals with measurable impact and outcome.
Demonstrated ability to apply a risk-based approach. Excellent written, verbal, and presentation communication skills and can translate complex concepts across all levels of the organization.
Excellent attention to detail, comfortable with ambiguity and complexity.
Excellent collaborator demonstrated ability to lead through change and identify opportunities resulting in positive business outcomes.
Excellent organizational agility and demonstrates obtaining results while strengthening internal and external relationships.
Able to influence decision-makers, utilizes sound problem-solving skills to recommend feasible options, and implements effective solutions.
Demonstrates strong time management and organizational ability to analyze and improve processes and consistently produce high-quality work.
Manages objective setting and balances commitments to prioritize and complete activities within established timelines and works well under tight timelines with the right-first-time results.
Withholds judgment to engage teams in addressing conflict positively by seeking diverse views and identifying options to achieve an equitable solution.
Models team spirit, culture, and ethics and drives across cross-functional teams to meet company objectives.
JOB COMPLEXITY:This role is critical to the success of the clinical and commercial programs and requires continuous communication to maintain alignment across the organization.
This role requires managing multiple competing priorities and the ability to evaluate data to detect weak signals, blind spots, and escalate cumulative risks.
WORKING CONDITIONS:This is an onsite position.Travel as required.
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