Director, QA Product Labeling

Company: Exelixis
Location: King Of Prussia
Posted on: June 25, 2022

Job Description:

Company DescriptionEvery Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.Cancer is our cause. Make it yours, too.Job DescriptionThe Director, QA Product Labeling is a QA professional managing GMP oversight of Clinical and Commercial Artwork and Labelling lifecycle and end product. Partners with quality, regulatory and operational teams to ensure label development, generation, review, and approval of current, compliant label information in all regions. Identifies and addresses issues and risks; escalates to ensure product quality. High level of independent judgment.QualificationsESSENTIAL DUTIES AND RESPONSIBILITIES:

• Directs QA programs to ensure GMP compliance of artwork and labelled material.
• Manages labelling review and approval.
• Manages artwork and labelling vendor oversight, icnluding contractors and development collaborators (contracts, validation, change management, deviation, CAPAs, other GMP QA issues).
• Leads cross-functional artwork and labellign teams.
• Resolves potential artwork and labeling product quality issues.
• Ensures that artwork and labelling is developed, generated, reviewed and approved to ensure curent, compliant label information in all regions.
• Manages review and approval of applicable artwork and labelling documentation and records, including documents submitted to regulatory agencies.
• Identifies and mitigates risk, proposes options and solutions, escalates timely.
• Leads process and system improvement initiations.
• Interprets current regulatory requirements and guidances, including compliance, and advises stakeholders and management on potential impact for the organization.
• Monitors current and proposed quality and scientific issues; advises on events applicable to Exelixis.
• Develops, tracks and manages periodic management reports including key QA metrics for assigned activities.
• Identifies and implements process and system improvements.
• Represents QA during audits and inspections; presents on quality issues. Performs GMP audits.Supervisory Responsibilities
  • Directly supervises employees.Education/Experience/Knowledge & Skills
    • Minimum BS/BA degree in related discipline (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of thirteen (13) years of related experience; or,
    • MS/MA degree in related discipline and a minimum of eleven (11) years of related experience; or,
    • PhD in related discipline and a minimum of eight (8) years of related experience; or,
    • Equivalent combination of education and experience.
    • Experience in the biotech or pharmaceutical industry is preferred.
    • Experience with clinical packaging/labeling activities is preferred.
    • Experience in assisting the development of business strategies, metrics, and continuous improvementsKnowledge/Skills
      • Demonstrated knowledge of commercial and clinical manufacturing, artwork and labelling, quality processes, US/EU regulations for pharmaceutical industry.
      • Interprets regulatory standards, provides insight into current processes, recommends modifications to corporate procedures. Working knowledge of ICH guidelines.
      • Extensive experience in a virtual manufacturing environment. Small molecule technical and oral solid dosage form knowledge required. Large molecule and biologics technical knowledge preferred.
      • Influencer, strong interpersonal, analytical, and business communication skills, driver, and negotiator. Builds productive internal/external working relationships.
      • Expertise/knowledge and skills contribute to development of company objectives and principles, achieves goals in creative and effective ways.
      • Interprets, executes, and recommends modifications to companywide policies and/or divisional programs.
      • Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
      • Leads/manages work of others. Provides guidance based on organizational goals and company policy.
      • Drives successful completion of major programs, projects, and objectives.
      • Detail oriented, precise execution of tasks and processes, multi-tasks.
      • Exercises independent judgment within defined procedures/practices to determine appropriate action.
      • Evaluates and generates data to support departmental metrics.
      • Manages significant, unique, and complex issues, including evaluation of intangibles, in-depth company knowledge.
      • Ensures budgets and schedules meet corporate requirements.
      • Implements technical solutions within quality requirements to complex problems
      • Excellent verbal and written communication skills.
      • Proficient in MS Office, including Excel and Power PointWorking ConditionsAlameda Campus-Based:
        • Primarily working in office, with occasional travel
        • Ability to travel approximately 25%Additional InformationDISCLAIMERThe preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Keywords: Exelixis, Philadelphia , Director, QA Product Labeling, Executive , King Of Prussia, Pennsylvania