Packaging Validation Team Lead

Foster City
See job description.
September 30 2021
Other, Other
Position Type
Full Time
Organization Type

Packaging Validation Team Lead
Ireland - Cork

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

Packaging Validation Team Lead role within the Validation Department, with a targeted focus on supporting Packaging day to day operations & projects in a dynamic environment. Flexibility & agility to support other validation workstreams as required to meet the business needs. Ability to integrate risk based validation strategies to site projects. Create and sustain a positive and energised team dynamic and environment.

Job duties include:
  • Responsible for leading the development of risk-based validation strategies for the implementation of validation projects and CAPEX programs.
  • Coordinating & scheduling the execution of packaging validation activities in alignment with planning & packaging functions.
  • Oversight of the validation compliance & delivery of CAPEX programs.
  • Provision of operational support for product launches, change assessments, deviations, CAPAs, etc.
  • Business Process Owner for the automated secondary packaging validation matrix.
  • Execution of internal product transfers between lines and vial inspection systems.
  • Qualification of new components and suppliers.
  • Preparation of workstream manning analysis to feed into Financial LE and budget cycles.
  • Coordinates the activities of assigned validation and contract personnel and ensures the quality & governance of completed work.
  • Leads the packaging validation team with respect to Goal & Objective setting, Coaching & Development, IDPs, 1:1, Performance Management preparation.
  • Foster validation team and cross functional working relationships to deliver site mandated programs of activities on schedule and to high performance standards.
  • Identify and drive functional continuous improvement initiatives to achieve compliant and lean sustainable solutions.
  • Reviews protocols, reports and data tables generated by peers and contract personnel.
  • Reviews packaging projects capital requests for resource estimations.
  • Represent packaging validation at cross functional governances with key stakeholders, on cross-functional project teams & functional / site MDI boards.
  • Presents validations in respective SME areas at internal and external audits.

Knowledge, Experience and Skills:
  • In-depth understanding and application of validation principles, concepts, practices, and standards including the application of ASTM E2500.
  • Extensive working knowledge of equipment and systems- specifically primary and secondary packaging; serialization and aggregation systems.
  • Knowledge of blister packaging a distinct advantage.
  • Knowledge of industry best practices.
  • Excellent verbal, technical writing, and interpersonal communication skills are required.
  • Operational excellence (lean and Continuous Improvement) mindset.
  • Proficient in Microsoft Office applications.
  • Leadership & management of direct reports- a distinct advantage.
  • Resilient profile with the ability to deliver in a dynamic environment.
  • Ability to engage and manage multiple stakeholders to achieve business objectives.
  • Learning agility across systems, equipment and new technologies.
  • Organised with systematic approach to prioritisation.
  • Process orientated to achieve the business objective.
  • Relevant experience and bachelor's degree in science or related field, MS or MBA.

Gilead Core Values
  • Integrity (always doing the right thing),
  • Teamwork (collaborating in good faith),
  • Excellence (working at a high level of commitment and capability)
  • Accountability (taking personal responsibility).
  • Inclusion (encouraging diversity)

Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

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