Job Description
My client a leading Pharmaceutical company now require a Quality Compliance Manager
to join their expanding team.
The Quality Compliance Manager has a leadership role in driving Quality Compliance at my client site to meet current FDA, EMEA and ATMP regulations for the manufacturing of non-sterile, sterile and biological pharmaceutical products. The Quality Compliance Manager will actively participate in global initiatives.
This is a permanent position based in Dublin and comes with a strong salary and benefits package. [JR1]
Responsibilities of Quality Compliance Manager
- Promote a culture of Quality Compliance on site
- Manage a team of Quality Compliance professionals
- Lead the preparation for, and hosting of, external audits from Regulatory Authorities and Global Quality
- Manage the site self-inspection and annual internal audit programs
- Oversee compliance with global standards and procedures
- Manage the site Quality Council Process and escalate Quality Compliance concerns to the Site Leadership Team
- Manage the process of escalating Quality Compliance issues to the global Quality organisation, including preparation of Quality Incident Notifications (QIN)
- Manage the site Customer Complaint process
- Perform Compliance gap assessments as requested by Global Quality
- Manage the preparation of Key Performance Indicators to align with company and global quality objectives
- Act as key site contact for regulatory affairs queries and discussions
- Manage preparation of documentation for regulatory submission
- Liaise with other departments on Quality issues (as required), providing guidance and support as required
- Work closely with other site Quality Managers and assume responsibilities in any of the Quality Department pillars in accordance with business needs
- Act as a designee to the Site Quality Head as required
- Implement Agile projects in the Quality Compliance area on a continuous basis
- Participate in site projects and initiatives and any cross functional training initiatives.
- Actively foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business
- Ensure timely completion of all SOP, reading, training and assessment.
- Comply with all site processes and procedures
- Perform other duties as required and directed by the Site Quality Head
Requirements of Quality Compliance Manager
- Minimum of 8 years’ experience in the pharmaceutical industry in a Quality role
- Minimum of 3 years’ experience in a people management role
- Minimum of 5 years’ experience in working in an aseptic manufacturing facility
- Excellent knowledge of Good Manufacturing Practice as described in current FDA, EMEA and ATMP regulations for non-sterile, sterile and biological pharmaceutical manufacture
- Ability to act as Subject Matter Expert for aseptic pharmaceutical manufacture
- Demonstrable experience managing, motivating and leading a team.
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below