Quality Assurance Manager

Job Description

Act as Gilead Turkey’s deputy of Responsible Manager (RM) after assignment by the Turkish Medicine and Medical Device Agency (TITCK), as per local Regulation on the manufacturing sites of medicinal products for human use dated 21 October 2017 and numbered 30217.
Support QA oversight of the local 3PL and Contract Manufacturing Organization (CMO) in Turkey as well as implementation & maintenance of the Turkish Affiliate Quality Management System (QMS).

This is an operational manager role with no direct reports.

Key Responsibilities:

• Management of final batch release of Gilead Turkey’s registered products and archiving of batch release documentation in accordance with Gilead’s retention policy and national requirements. This includes batches imported into Turkey from Gilead Sciences Ireland Unlimited Company (GSIUC) and batches manufactured locally by CMO.

• Final release of investigational product batches as per local requirements.

• Support development of the Affiliate’s Quality Management System (QMS), including generation of new Standard Operating Procedures (SOPs) and User Manuals.

• Generate and revise controlled documentation (e.g., procedures, work instructions, forms, specifications, protocols, reports, etc.).

• Perform administration of the Quality Management System, including coordinating the distribution and maintenance for GxP documentation.

• Support processes for continuous improvement and management review process, e.g. CAPA management, change management, self-inspection etc.

• Support generation of monthly document control metrics.

• Support management of local complaints, including reporting to GSIUC or CMO, collecting and shipping samples, following up on investigation results and communicating with complainant.

• Support investigations into potential falsified products which impact products registered in Turkish market.

• Perform a variety of activities to ensure compliance with applicable regulatory requirements.

• Provide support to internal and regulatory audits/inspections, as required.

• Participate in the development of training materials and delivering training to Affiliate personnel.

• Conduct gap analyses and support risk assessments of processes & procedures against relevant GDP guidelines as well as corporate standards, as required.

• Management of supplier/customer qualifications, where needed.

Knowledge, Experience & Skills:

• Demonstrates good working knowledge of regulations and guidelines associated with distribution supply chain of medicinal products & medical devices.

• Demonstrates excellent working knowledge of quality assurance systems, methods and procedures as well as proficiency in application of QA system principles, concepts, industry practices, and standards.

• Demonstrates audit and investigation skills, and report writing skills.

• Demonstrates very good verbal, technical writing, and interpersonal communication skills.

• Excellent verbal and written English language skills.

• Demonstrates proficiency in Microsoft Office applications.

Typical Educational Experience & Competencies

• 7+ years of relevant experience in a GMP/GDP environment related field and a BS or BA.

• 5+ years of relevant experience and a MS.

• Demonstrates ability to effectively manage multiple projects/priorities at any one time, and to work to tight deadlines.

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

• Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.

• Demonstrates clear personal responsibility for own work, in terms of both the 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 organizational strategy.