Associate Director, QA/QP Biologics
|Contact Name:||Laurentina Kennedy|
The Associate Director Development QA will be responsible for PDQA oversight of CMC development projects at Contract Manufacturing Organisations to ensure compliance with policies and procedures and Regulatory expectations, and timely supply of Investigational Medicinal Products (IMP) to Clinical Trials. You will be involved significant cross-functional collaboration with other functions including PDMS (manufacturing and analytical), CMC regulatory, CTSM, Medical Affairs and senior leaders.
This role is both project and operations orientated. It shall require an ability to drive and deliver multiple projects concurrently and feed into the broader functional strategy.
The Associate Director will be reporting directly to the Director of PDQA,
The Associate Director Development QA is responsible for monitoring and supporting the quality performance of contract manufacturers and material suppliers to all applicable standards for GMP. The Associate Director Development QA will lead the day-to-day quality activities relating to pharmaceutical development projects and shall provide quality direction in relation to issues that arise within product development teams, contract manufacturing organisations and material suppliers, to all applicable GXP standards. The Associate Director Development QA role includes cross-functional team membership/collaboration, providing guidance for quality aspects of CMC regulatory dossiers and performing disposition of IMP to Clinical Trials.
Act as a Qualified Person (QP) named on Manufacturing and Import Authorisation (MIA) for Investigational Medicinal Products (IMP) to ensure clinical trial supply
Lead as a quality representative on CMC Product teams for assigned development projects. In this role the individual shall be responsible for making quality related decisions and demonstrating critical thinking skills, ensuring that phase appropriate GMP is implemented
Lead other PDQA representatives on the CMC Product Team(s) to influence and impact their decision making in a positive manner
Ensure compliance of all respective contract manufacturers to both internal requirements and country specific regulations
Lead and monitor the IMP manufacture at CMO, perform review and approval of batch records, deviations, investigations, change controls, product complaints and perform QP disposition
Contribute and provide SME quality support for the successful outcome of all regulatory inspections, both internally and at contract manufacturers, packagers and laboratories, as required
Liaise with the relevant departments within the business and work closely with the Pharmaceutical Development & Manufacturing Sciences (PDMS) and Clinical Trial Supply Management (CTSM) to ensure agreed milestones/targets are met
Work closely with the CTSM to ensure supply of clinical trial material to clinical development programs
Highlight any risks associated with maintaining supply of clinical trial material to all stakeholders and offer innovative and effective ways to mitigate such risks
Prepare and/or act as an SME for Quality Technical Agreements within PDQA, as required
Facilitate technology transfer, process scale-up and process improvement projects i.e. drive the transitioning of development products from the Investigational Medicinal Product space to Commercial Medicinal Product space
Monitor and support the quality performance of contract manufacturers and material suppliers and provide information to the Supplier Review Board in the context of development projects
Lead vendor audits and vendor site visits, as required
Review new critical regulations and guidelines, as they apply to product development from a quality perspective and advise and assist with their implementation.
Responsible for the successful, timely completion of goals and objectives that will strengthen the PDQA team
Provide advice on quality issues that may arise, including initiating/directing appropriate risk management activities
Perform PDQA activities to support the product development pipeline from a science led, risk based, patient focused approach.
Contribute to the design and implementation of best practice quality improvement programs and company expansion programs
Contribute to the development of quality policies and procedures as they relate to development products in order to ensure best practice and compliance
Contribute to the development of new drug products, to assist as they deliver a robust product pipeline
Work closely with other members of matrix CMC teams to ensure delivery of key project objectives and timelines
Foster a positive employee relations environment and a culture of continuous improvement and teamwork through the use of consistent management principles
Act as a PDQA representative at external meetings
This position will require up to 20% travel
Bachelor’s degree in chemistry, biology, pharmacy or a related science discipline
Eligibility to act as a licensed Qualified Person
10+ years of practical experience in the Pharmaceutical Industry in QA or QC role(s) with a thorough understanding of GMP and Quality Systems as they relate to product development
Ideally have significant experience (5-10 years) in drug development (Phase 1-IV) and cGMP including broad exposure to multiple dosage forms and finished pharmaceutical products
Have experience in implementing and following phase appropriate GMP with regard to manufacture and testing of IMP
Capability of grasping complex technical issues and making sound decisions based on data and information from various sources
Experience with third party vendor auditing, out of specification investigations, deviations, product complaints and change control
Operational experience and technical understanding of standard manufacturing and packaging processes for a variety of dosage forms
Experience working with contract manufacturing organizations
Must be able to critically evaluate completed manufacturing documentation and assess to determine compliance with SOPs and regulatory documents
Experience interfacing with regulatory bodies and working on regulatory submissions
Good technical and QA background, having a good understanding of analytical method development and validation and specification setting
Experience in defending processes, procedures and investigations during FDA/EMA (or other competent authorities) inspections desirable
Knowledge of US and EU GMP guidelines and their implementation for CMC product development
Experience of CMC regulatory requirements for pharmaceutical products
Demonstrated track record of training and coaching colleagues to improve overall team process knowledge and performance
Demonstrated track record of delivering positive results on a consistent basis
For further information on this Associate Director, Pharmaceutical Development Quality Assurance (PDQA), Quality Operations position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie.
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