Sr Manager, Quality Assurance

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, Quality – Global Product Distribution & Affiliates (GPD&A) will manage and maintain the local Quality Management System in-country, carry out QA duties, including local lot release, and will work with internal & external stakeholders to ensure quality requirements are met for Gilead  products, throughout the distribution network, and within the market, all the way to patients. This role will also be responsible for QA oversight of distribution partners for Sub-Sahara Africa region. 

Key Responsibilities:

•    Establish and maintain the Quality Management System in SA Affiliate to ensure that it meets local regulatory and industry standards and Gilead expectations.
•    Perform QA activities for export of products to neighbouring countries (as appropriate)
•    Perform local lot release for Gilead products imported for sale in South Africa
•    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.
•    Support the maintenance and renewal of SAHPRA GMP/GDP license
•    Be a contact for the SAHPRA 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 activities
•    Manage 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 manufacturing sites and local GMP/GDP related suppliers/service providers.
•    Review and create local 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 relabelling/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.
•    Perform QA oversight activities of Gilead’s Distribution Partners in the region
•    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.
•    Manage all post-importation testing and related activities

Knowledge, Experience & Skills:

• Highly organized 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

• Must reside in South Africa and be fluent in English (written and spoken).

• Master's or B. Pharm degree with extensive relevant experience in a GMP or GDP environment-related field

• Must be registered with the South African Pharmacy Council (SAPC) as a pharmacist

• 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 way 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, organization skills and interpersonal communication skills required.

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

• Strong communication 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.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.