Associate Director Global Quality Assurance Biologics
|Contact Name:||Larry O’Leary|
Our client, a fast growing highly profitable multinational biopharmaceutical company in Dublin, with an exciting pipeline of drugs coming through development. Rapid expansion has led to need to hire an Associate Director for Quality Assurance for all Biologic and plasma products complaints operating within the Marketing Surveillance department on a global team.
Job Purpose: responsible for leading and managing the product complaints team and all related activities associated with the complaint handling program for Biologic and Plasma products, per corporate procedure and regulatory standards including goal setting in-line with corporate strategy and priorities and the Global Quality road map. Proven experience in writing investigation summaries and complaint responses is required in this role.
Scope: includes all clinical and commercial biologic and plasma products, originating from a market complaint in the EU & ROW region (excluding North America).
The successful candidate will be the Subject Matter Expertise in assigned product platform (Biologics and Plasma) and a strong working knowledge of the complaints process or multiple pharmaceutical quality management systems.
Key Responsibilities of Associate Director Quality Assurance Biologics:
Timely management of the complaint processes to comply with corporate procedures, EU and FDA regulations, ISO13485 and other regulatory requirements as applicable.
Escalate and participate in resolution of potential product deficiencies for all applicable products originating from a market complaint.
Liaise with Internal Stakeholders, Call Centres and service providers to ensure they support company corporate policies and guidance while aligning with all of the necessary regulations and standards.
Serve as the Quality liaison between individuals and business units within or outside the organization regarding matters related to product complaint activities, including risk management, regulatory inspections and complaint handling processes for all applicable products.
Serve as point of contact for commercial & clinical product complaints and post market product vigilant monitoring processes
Receive, process, and initiate product complaint investigations using the current product complaints management software and coordinate all aspects of investigation through closure and/or provide oversight for complaint handling process.
Interface and collaborate with various departments including the OpUs, External Supply, QA, Regulatory, Development, Safety/Pharmacovigilance, etc. and the regional organisation. Interface with external stakeholders such as CMO, Call Centres and vendors/contractors on product complaint issues.
Assure that all product complaints are investigated to the appropriate level within the required timeline.
Critically review and approve all investigation
Represent company as SME for the product complaints process during Internal, External and Regulatory Body Inspections.
Drive continuous Improvement
Requirements for Associate Director, Quality Complaints Management:
Bachelor's degree with a minimum of 12 years of experience in Quality Assurance or a GMP related field within Medical device, biotechnology or pharmaceutical manufacturing.
Ideally QP Qualified and named on a manufacturing licence releasing biologic products.
Working knowledge of cGMPs and other regulatory requirements governing combination drugs and device products.
Knowledge of EU/ FDA cGMP requirements pertaining to drug/device product complaints reporting and investigation.
Desirable experiences: combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits.
Good understanding of the manufacture of combination products and the linkage to customer complaints.
Strong attention to detail, good organizational skills and well-structured.
Excellent troubleshooting and problem-solving skills.
Skill in writing investigation summaries and complaint responses.
Independent, organized and able to schedule work without supervision to meet schedule deadlines.
Ability to work independently as well be an effective team member and leader.
Approachable and possess the ability to forge solid working relationships with colleagues across all functions, its partners and contractors.
For further details, please contact; Larry on +353 1-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. http://www.rftgroup.ie/
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