Associate Director, Quality–Global Product Distribution & Affiliates

at  Gilead Sciences

For Current Gilead Employees and Contractors:
Please log onto your
Internal Career Site
to apply for this job.
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.
Job Description
Role Purpose:
The Associate Director, Quality – Global Product Distribution & Affiliates (GPD&A), will work collaboratively with the rest of the GPD&A team plus internal & external stakeholders to ensure quality requirements are met for Gilead products, throughout the distribution network, and within each market, all the way to patients.

Key Responsibilities:

• Direct the operations of the Central Operations group within GPD&A to ensure that processes and procedures are in place for:
• Managing the onboarding, off boarding, maintenance and management of Distributors and Distributors/Packagers from a Quality perspective
• Providing Affiliate Support via the Corporate Quality Support Model (CQSM) specifically:
• Ensuring that appropriate QMS Procedures (Global if possible) in line with PDM Quality are in place to facilitate carrying out of Quality Responsibilities by the Regulatory Affairs personnel who are responsible for Quality at their Affiliates.
• Ensuring appropriate communication fora are agreed, scheduled, and managed to facilitate information exchange and discussion of Quality issues.
• Ensuring all Central Operations personnel have appropriate knowledge of Gilead’s Quality Processes and Systems so that they can provide Affiliate support as required under the CQSM.
• Manage resources creating an energising team environment to ensure comprehensive and timely support of Affiliate, Distributor and Distributors/Packager requirements under GPD&A responsibility.
• Co-ordinate/manage GPD&A projects as required.
• Manage the annual product recall challenge & support product recall, as required.
• Support the Director GPD&A as required, with Escalations and other Quality requirements.
• Pivot to support other groups across the GPD&A team as required.
• Ensure that GDP training for Gilead, Distributor and Distributors/Packager personnel is prepared and carried out in an efficient and timely manner reflecting current issues and requirements.
• Ensure the generation, maintenance and enhancement of the GDP&A Procedures, Quality Agreement Templates, other controlled documents (e.g., forms, reports) and supporting documents, as appropriate, to ensure compliance with applicable quality objectives and regulatory requirements.
• Ensure that there is an appropriate record management system in place such that information can be readily shared across the team.
• Support initial due diligence checks of potential new distributors or Distributors/Packagers.
• Manage the Quality Agreements program between Gilead Product suppliers and Gilead Affiliates, Distributors and Distributors/Packagers.
• Ensure the consistent documentation, review & approval for in-market GMP/GDP activities performed by 3rd parties.
• Perform & Support gap analysis and risk assessments on processes within Affiliates, Distributors and Distributor/Packagers wherever they may be required, to evaluate compliance with relevant GDP regulations/guidelines & implement/support the implementation of corrective actions.
• Collaborate cross-functionally with global colleagues (Supply Chain, Commercial Operations, Corporate Quality, Customer Service) to identify and implement process improvements in distribution of finished products.
• Support internal and external compliance audits as required, including audits of potential new Distribution Partners, current Distribution Partners and Gilead Distribution entities.
• Lead or co-ordinate investigations and corrective and preventative action recommendations as required.
• Participate in inter-site global projects in the area of distribution of Finished Products.
• Support regulatory inspections of GSIUC (Cork and Dublin facilities) as required.
• Perform QA activities supporting Global Product Distribution and Affiliates (GPD&A) team as required.

Knowledge, Experience & Skills:

• Demonstrates proficiency in Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) requirements.
• Familiar with the concepts of supply chain dynamics between freight forwarders, carriers and handlers related to the supply and delivery of pharmaceutical or similar materials.
• Understands the time & temperature sensitivity of pharmaceutical material and concepts related to product stability, product labelling and risk management.
• Demonstrates knowledge of regulations and guidelines associated with distribution supply chain of medicinal products and medical devices.
• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
• Demonstrates understanding of international quality system regulations to enable adoption of best-in-class systems/processes.
• Demonstrates working knowledge of, with good proficiency in, Microsoft Office applications.
• Demonstrates working knowledge of, with good proficiency in, Risk Management tools (e.g., Failure Mode Effects Analysis (FMEA).
• Knowledge of Six Sigma, Define-Measure-Analyse-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods.
• People Leader skills and experience.

Educational Experience & Competencies

• Significant amount of experience in a GMP/GDP environment and a BSc /BA or MSc /MA.
• Ability to work on own initiative as well as having strong teamwork skills.
• Prior people management experience.
• Knowledge and experience in quality assurance in a highly regulated environment.
• Eager to learn and develop within the role and the organisation.
• Demonstrates excellent verbal communication, technical writing and interpersonal skills.
• Demonstrates ability to effectively manage multiple projects/priorities and to work to tight deadlines.
• Demonstrates clear personal responsibility for own work, in terms of both the quality of the work and the manner in which it is performed.
• Ability to initiate and support change and respond to change requirements by continually striving to improve working processes and systems, consistent with the organisational strategy.

.
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:
Please log onto your
Internal Career Site
to apply for this job

• Direct the operations of the Central Operations group within GPD&A to ensure that processes and procedures are in place for:
• Managing the onboarding, off boarding, maintenance and management of Distributors and Distributors/Packagers from a Quality perspective
• Providing Affiliate Support via the Corporate Quality Support Model (CQSM) specifically:
• Ensuring that appropriate QMS Procedures (Global if possible) in line with PDM Quality are in place to facilitate carrying out of Quality Responsibilities by the Regulatory Affairs personnel who are responsible for Quality at their Affiliates.
• Ensuring appropriate communication fora are agreed, scheduled, and managed to facilitate information exchange and discussion of Quality issues.
• Ensuring all Central Operations personnel have appropriate knowledge of Gilead’s Quality Processes and Systems so that they can provide Affiliate support as required under the CQSM.
• Manage resources creating an energising team environment to ensure comprehensive and timely support of Affiliate, Distributor and Distributors/Packager requirements under GPD&A responsibility.
• Co-ordinate/manage GPD&A projects as required.
• Manage the annual product recall challenge & support product recall, as required.
• Support the Director GPD&A as required, with Escalations and other Quality requirements.
• Pivot to support other groups across the GPD&A team as required.
• Ensure that GDP training for Gilead, Distributor and Distributors/Packager personnel is prepared and carried out in an efficient and timely manner reflecting current issues and requirements.
• Ensure the generation, maintenance and enhancement of the GDP&A Procedures, Quality Agreement Templates, other controlled documents (e.g., forms, reports) and supporting documents, as appropriate, to ensure compliance with applicable quality objectives and regulatory requirements.
• Ensure that there is an appropriate record management system in place such that information can be readily shared across the team.
• Support initial due diligence checks of potential new distributors or Distributors/Packagers.
• Manage the Quality Agreements program between Gilead Product suppliers and Gilead Affiliates, Distributors and Distributors/Packagers.
• Ensure the consistent documentation, review & approval for in-market GMP/GDP activities performed by 3rd parties.
• Perform & Support gap analysis and risk assessments on processes within Affiliates, Distributors and Distributor/Packagers wherever they may be required, to evaluate compliance with relevant GDP regulations/guidelines & implement/support the implementation of corrective actions.
• Collaborate cross-functionally with global colleagues (Supply Chain, Commercial Operations, Corporate Quality, Customer Service) to identify and implement process improvements in distribution of finished products.
• Support internal and external compliance audits as required, including audits of potential new Distribution Partners, current Distribution Partners and Gilead Distribution entities.
• Lead or co-ordinate investigations and corrective and preventative action recommendations as required.
• Participate in inter-site global projects in the area of distribution of Finished Products.
• Support regulatory inspections of GSIUC (Cork and Dublin facilities) as required.
• Perform QA activities supporting Global Product Distribution and Affiliates (GPD&A) team as required