The Quality Compliance Manager has a leadership role in driving Quality Compliance on the site, to meet current FDA and EMEA regulations for manufacture of non-sterile, sterile and biological pharmaceutical product.
This is a key position on site, and as such, is part the site Extended Leadership Team. In addition, the Quality Compliance Manager is a part of a global network of Quality Compliance Leads and will actively participate in global initiatives.
Key responsibilities of the Quality Compliance Manager include the following:
• 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
• Primary Degree in Scientific discipline
• Minimum of 10 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
SKILLS / COMPETENCIES:
• 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.
• A high level of initiative
• Excellent verbal and written communication skills
• Strong project management and organisational skills.
• Ability to adapt to changing priorities
For a confidential discussion on this opportunity, please contact Jenny Navan on 01 614 6072 or via email email@example.com