Sr Managerr/RP, PDM Quality – Global Product Distribution & Affiliates (GPD&A) UK.

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.
 

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.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

The Senior Manager/RP, Quality – PDM Quality Global Product Distribution & Affiliates (GPD&A) UK will manage and maintain the local Quality Management System in-country, carry out RP duties for both Gilead and Kite products and will work with internal & external stakeholders to ensure quality requirements are met for Gilead and Kite products, throughout the distribution network, and within the market, all the way to patients.

Key Responsibilities:

·         Establish and maintain the Quality Management System in UK Affiliate to ensure that it meets local regulatory and industry standards and Gilead expectations.

• Perform Responsible Person for import (RPi) activities to ensure compliance of products imported into UK from an approved country on import list as per MHRA guidance

• Ensure strong relationships and good communication with functional areas of the local organisation (Regulatory Affairs, Medical Affairs, Commercial, Market Access, Legal, etc.) and PDM Quality and ensure that they have up to date information relating to product quality and quality distribution issues (as appropriate) in order to ensure the success of local and international business requirements.

• Maintain WDA(H), Manufacturers Specials Licence and MIA(IMP) license in the UK, as required.

• Be a contact for the MHRA in the UK on quality issues.

• Ensure management of authorised activities and accuracy of quality records

• Manage local process of change control, deviation, CAPA and supplier management.

• Manage interactions with the Manufacturing Plant in relation to all GDP activitiesManage local Quality Management Review process.

• Participate in Gilead’s Quality Escalation process for critical GDP quality issues, and regulatory compliance issues.

• Management/support of product out of stock situations.

• Ensure that initial and continuous GDP training programmes are implemented and maintained for local affiliate personnel working on quality/distribution matters.

• Ensure up to date organograms, training curricula pertaining to GMP/GDP, training records, CVs, and Job Descriptions are in place for local affiliate personnel working on quality/distribution matters.

• Establish and maintain the Affiliate Quality Manual and GMP/GDP procedural documents.

• Establish and maintain the Quality Agreement with 3PL/4PL, with Gilead and Kite manufacturing sites and local GMP/GDP related suppliers/service providers.

• Review Annual Product Quality Reports (as applicable)

• Ensure shipping conditions match the product license/product label particulars and transporters/transport solutions are appropriately qualified.

• Support Customer Services with enquiries of a GDP nature such as delivery issues, transportation conditions, disputes, etc.

• Work with 3PL/4PL, provide guidance on supply related issues.

• Arrange authorised relabeling/repackaging in cooperation with 3PL/4PL (where applicable)

• Support the management of quality and distribution complaints.

• Support the investigation of fraudulent and counterfeit medicinal products.

• Manage product return and destruction as required.

• Decide on the final disposition of returned, rejected, recalled or falsified products, and approve any returns to saleable stock.

• Manage local recalls and participate in supplier’s recall challenge or perform local mock recall as needed.

• Qualify and manage local 3PL/4PL and support audit of 3PL/4PL.

• Qualify and manage local GMP/GDP related suppliers/service providers, auditing and approving these according to local requirements.

• Assure customers validation for new/existing customers and adequate records compliance to Gilead QA requirements are established and maintained for all local distributors/customers.

• Collaborate with RA to support inspections and audits.

• Manage the Affiliate self-inspection program.

• Support audit of distributor (where applicable).

• Serve as a core member of the country brand/launch team or international working group as the representative of Quality at the affiliate.

• Keep appropriate records of any delegated duties.

• Execute goals and objectives in line with the PDM Quality strategy and the local Business vision.

• Represent Quality within internal cross-functional and/or cross-regional Projects.

Knowledge, Experience & Skills:

• Highly organised individual with a strong work ethic and ability to work flexibility and independently.

• Demonstrate proficiency in Good Manufacturing Practices (GMPs) and/or Good Distribution Practices (GDPs).

• Demonstrate proficiency in application of QA principles, concepts, industry practices, and standards.

• Demonstrate proficiency in Quality Systems processes (Deviation, CAPA, Change Control, Complaints, Supplier Management, etc.).

• Demonstrate a knowledge of regional/local regulatory requirements and industry standards.

• Demonstrate proficiency in Microsoft Office applications, particularly, WORD, Excel, PowerPoint, and Teams. Familiarity with technology platforms such as Veeva Vault, SAP ERP, etc.

• Working knowledge of Risk Management tools (e.g., Failure Mode Effects Analysis (FMEA) is preferred.

Educational Experience & Competencies

• University degree in pharmacy, chemistry, medicine, biology or a related life science, experience is in the UK market.

• Must reside in the UK and be fluent in English (written and spoken).

• Bachelors’ degree and relevant experience in a GMP or GDP environment-related field

• Masters’ degree and relevant experience in a GMP or GDP environment related field.

• Must be a member of a professional body with a published code of conduct

• Ability to work on own initiative as well as display strong teamwork skills.

• Demonstrate 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 support change and respond to change requirements by continually striving to improve working processes and systems, consistent with the organisational strategy.

• Excellent verbal, written, organisation skills and interpersonal communication skills required.

• A proactive and positive mind-set and can-do attitude is essential.

• Strong influencing and negotiation skills, with the ability to engage effectively and negotiate with stakeholders, including Health Authorities. Demonstrate leadership skills with a sphere of influence externally, cross-functionally and within the affiliate. 

• Previous project management experience is beneficial. 

• Good decision-making skills are important.

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: