Job Description
The QA Director position requires a leadership role working with key stakeholders, including of management of external & internal providers and with client organisations, to promote processes and performance in support of a culture of quality, customer interactions for QA and prevention of quality issues.
Plays a crucial role in the business by ensuring that products meet the standards and all external and internal requirements set by the industry and our customers.
Assures consistent quality of production (internal and external) by developing and enforcing good manufacturing practice (GMP) systems, validating contract manufacturers (CMO) and processes, providing documentation and managing staff.
The QA Director is responsible for management and oversight of staff for delivery and adherence to Quality Agreements, or similar (where applicable), Project Specific Quality Assurance & Audit Plans, QA interactions with clients, and oversight of CAPA for escalated quality issues. The QA Director will represent QA Leads and manages staff in support of management of client and/or contractor audits including CAPA oversight and coordination with internal stakeholders in management support across regulatory inspections
Make sure all necessary licenses are obtained and adapted according to the markets we are working in.
Duties
Management and oversight to QA staff, ensuring quality of QA
QA interactions with Clients and Contractors in support of quality plans, issue escalation and notification, corrective and preventive actions to client-specific issues and quality governance
Representation and direction to staff in support of client and contractor audit management; including preparation, audit hosting and CAPA response to client audit reports/outcomes as applicable
Coordination of QA support to client & contractor -specific regulatory inspection management (e.g.; inspection of investigator sites) and management of staff in support of activities as applicable
Collaborate with internal teams and functions and other internal stakeholders (e.g; Legal) with respect to QA Engagement operations, client/ contractor interactions and quality issues
Management of development, maintenance and adherence to execution of Quality Agreements (where applicable) and study-specific Quality Plans (where required) with Clients and Contractors
Contribute to evolving standards and requirements for QA Lead Engagement processes, including operational execution and continuous process improvement
Represent QA Lead Engagement in developing quality assurance approaches/strategies with Clients and external operations
Serve as QA lead representation to operational and/or quality governance as appropriate
Serve as key point of QA contact in client and/or contractor capability
Talent management, colleague performance management, development and engagement
External auditing of the component suppliers and contractors when required (with the QP)
Liaise with the RA (regulatory affairs department) in relation to Marketing Authorisation and variations
Preparation of Quality Quarterly reports
Ensure that all activities are in compliance with the requirements of Good Manufacturing Practice
Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company
Education/Qualifications
? University/college degree, BA/BS (life science preferred) or equivalent experience
Preferred:
? Masters or other advanced degree (e.g. postgraduate qualification in Quality Assurance) or equivalent experience a plus
? 10 years? experience in a regulated environment (MUST include significant experience in GMP) in roles of a related discipline (e.g. Quality Assurance, Operations, Project Management),
? 10 years? experience in pharmaceutical/CMO/CRO industries
? Proven ability to manage complex quality issues and deliver against quality strategies in a global clinical setting
? Proven ability to understand, analyze and communicate the impact of GMP quality issues affecting the drug development process and the future supplies
? Working knowledge of GMP processes and Pharmacovigilance standards and quality and compliance processes (e.g. audit, compliance, CAPA)
For further information on this Quality Assurance Director position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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