Associate Director, Document Management System at Exelixis in Alameda, CA

Job Description

The Associate Director of the Document Management System (DMS) is responsible for development, execution and maintenance of the GxP document system. As the Business Process Owner, this leader is responsible for managing the document pyramid, identifying and creating the appropriate documents, and leveling them properly across the GxP areas. The leader will maintain the document structure that aligns the proper level of GxP across the organization, creating and managing a strategy that allows the system to scale and align with business drivers. This leader would be the single point of contact and would author certain policy documents, review Quality documents and chair the Document Review Committee (DRC) to adjudicate new or updated documents.

This position requires a broad range of knowledge and experience with quality document architecture, with an understanding of how the documents work together to create a system that covers drug development. This requires a deep understanding of Health Authority rules and regulations as well as international standards and guidelines. This candidate would influence across several disciplines in order to deliver a clear strategy to maintain and improve product quality. The incumbent must possess technical expertise in the areas of responsibility and demonstrate technical and personnel leadership qualities.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop and maintain a document management system from non-clinical development through the life of the program, including commercial launch, in alignment with commercial business drivers and process development capabilities.

• Provide organizational management of the Document Management System and infrastructure improvements.

• Ensure GxP controlled documents adhere to quality standards

• Continuously assure the proper number of documents at the right level of instruction.

• Provide quality perspective and expertise as the single Point of Contact for document management. Escalate issues as appropriate.

• Interpret and apply applicable Health Authority regulations and guidance across the document management system. Review new regulations and guidance on a frequent basis to assure we retain compliance.

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

• Support document structure that allows a seamless transition from clinical to commercial, new product introductions and tech transfers across the network.

• Ensure alignment of document changes, partnering with key colleagues to develop strategies that assure the documents are written and released in a timely fashion.

• Excellent writing skills and editing, formatting and organization skills.

• Excellent attention to detail and customer service attitude

• Define and oversee the tracking and trending of quality metrics related to document control processes.

SUPERVISORY RESPONSIBILITIES:

• Supervise direct reports.

EDUCATION/EXPERIENCE/SKILLS:

Education:

• Bachelor’s degree in life sciences or engineering and ten years of related experience; or,

• Master’s degree in life sciences or engineering and eight years of related experience; or,

• PhD in life sciences or engineering and six years of related experience, or;

• Equivalent combination of education/training and experience

Experience:

• Minimum of 10 years’ experience in biotech, pharmaceutical or related industry

• 4+ years of previous people management, either direct or indirect team leadership.

• Demonstrated knowledge of camp’s, Health Authority Regulations, Quality Systems and technical expertise in DS/DP/FG manufacturing processes. Knowledge of biologics and chemical moieties, devices, and combination products desirable.

• International/global experience preferred.

• Proven organizational and management skills to coordinate multi-discipline project groups

• Ability to speak, present data, and defend approaches in front of audiences.

• Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.

• Understanding of FDA & European regulatory requirements, guidelines, and recommendations for process validation expectations.

Knowledge/Skills/Abilities:

• Deep knowledge and understanding of drug development process and the Global Regulatory Requirements and regulations related to GXP.

• Broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals with measurable impact and outcomes.

• Strong written and oral communication skills, able to translate complex concepts across all levels of the organization.

• Strong collaboration skills and demonstrated ability to lead change and identify opportunities that have resulted in positive business outcomes.

• Excellent organizational agility that demonstrates how to get results while strengthening internal and external relationships.

• Consistently demonstrates managerial courage to make timely decisions without complete data to ensure quality product to patients.

• Consistently demonstrates sound quality judgement and balances between business, supply and quality aspects.

• Ability to influence decision makers and utilizes sound problem solving skills to recommend options and implement effective solutions.

• Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.

JOB COMPLEXITY:

• This role requires a skillset that includes the ability to lead change by engaging others, assessing unforeseen situations, failing fast and continuously learning to achieve a goal.

• This role is critical to the success of the clinical program and requires continuous communication to maintain alignment across the organization.