Job Description
Our client, a leading multinational biotech company with innovative therapies, now seek an experienced Quality Assurance Senior Manager, who will lead QA Operations across multiple products through to commercial manufacture and have full responsibility for management of experienced QA team, including QPs. This role in act as a designee to the company Site Head of Quality as required.
The successful candidate will have full responsibility oversight of all Quality Assurance biotech operational activities including; batch disposition and material status control activities, batch manufacturing records, leading investigations and audit preparation within sterile manufacturing facility. Strong leadership is required, leading function, team and facility from a Quality perspective.
This is a highly visible role within this company and Quality function globally; excellent prospects for further development and opportunity for progression.
Responsibilities for Associate Director Quality Assurance:
Taking a leadership role in promoting a Quality culture of Compliance across the organisation.
Implementation of KPIs within the Quality Assurance area to align with company and global quality objectives.
Ensuring effective participation of the Quality Assurance team in production and other site meetings.
Management of QA oversight of routine manufacturing, testing and relating activities to ensure ongoing cGMP compliance.
Participation in the preparation of and hosting of both internal and external cGMP audits, including from Regulatory Authorities and Global Quality.
Management of review of Batch Manufacturing Records (BMRs).
Management of investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
Management of the Change Control process, ensuring controlled implementation of all GMP related changes.
Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.
Motivation, training, discipline and appraisal of Quality Assurance staff.
Responsibilities for Associate Director Quality Assurance:
Bachelors Degree in Scientific discipline. Advanced qualifications such as MSc or PhD is preferred.
Qualified Person certification is preferred, with ideally 3+ years relevant experience of such.
10+ years Quality Assurance experience in the Pharma / Biopharma industry, working with sterile manufacturing, across multiple forms.
3+ years’ experience in a people management role, with demonstrable experience managing, motivating and leading a QA team.
Excellent knowledge of cGMP as described in current FDA & EMEA regulations for pharmaceutical manufacture.
Strong project management and organisational skills.
Excellent verbal and written communication skills are essential.
Please phone Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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