Director, QA Product Labeling
Location: King Of Prussia
Posted on: June 25, 2022
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
- Directs QA programs to ensure GMP compliance of artwork and
- 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
- 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
- Identifies and mitigates risk, proposes options and solutions,
- 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 &
- 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
- 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
- Experience with clinical packaging/labeling activities is
- 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
- 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
- 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
- Detail oriented, precise execution of tasks and processes,
- Exercises independent judgment within defined
procedures/practices to determine appropriate action.
- Evaluates and generates data to support departmental
- 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
- Excellent verbal and written communication skills.
- Proficient in MS Office, including Excel and Power PointWorking
- 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
Didn't find what you're looking for? Search again!