Quality Manager Pharma - Ireland
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- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- Reporting to the Director of Quality and as part of the site Quality leadership team, the Pharm Ops Quality Manager (Formulation and R&D Facility) is responsible for management of compliance and cGMP in the Pharm Ops facility.
- The Quality Manager is responsible for providing guidance on the Quality Assurance and Regulatory Compliance to the Production area.
- This includes supporting and improving the quality systems, maintaining awareness of regulatory developments and communication of these trends and developments to the Production team. In addition the Quality Manager is responsible for management, training and development of Quality staff.
- Provide Production support and Quality Compliance insight and guidance as appropriate to ensure the Pharm Ops facility meets all GMP requirements for development, clinical and commercial supply of OSD products.
- Actively participate in development and improvement of site Quality systems.
- Actively participate in preparation and approval of site documentation including policies, procedures, associated reports and annual reviews.
- Provide Quality expertise for Site Based Risk Assessments.
- Act as lead auditor for the GMP audit/inspection program for the facility, systems (including automation systems) and operations.
- Provide training on compliance issues as appropriate and promote GMP validation awareness at the site.
- Manage the Quality Assurance team to ensure timely and effective completion of the QA core functions in accordance with schedules and company policies, procedures and guidelines.
- Assist with preparation of budgetary reports and provide information for annual profit planning activities.
- Identify gaps and provide training on GMP and compliance issues as appropriate.
- Participate in site projects that may arise.
- Act as lead QA auditee for the Pharm Ops facility during regulatory, customer or corporate inspections.
- Manage Customer Complaint Investigations and deviation investigations through to approval.
- Provide leadership to the Quality Team including employee develop and performance management.
- Minimum of 7 years Pharmaceutical industry experience within a GMP environment
- Extensive knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements
- Experience in GMP auditing across multiple Quality Management systems in API and/or Drug Product including Computerised System, Supplier Management and Logistics/Warehousing
- Experience with compliance / regulatory requirements for clinical in addition to commercial drug product
- Experience with CMO interactions & release of CMO drug product
- Experience with product and cleaning validation requirements in Drug product facility
- Experience working directly with regulators in audit situations
- Ability to build relationships and influence across disciplines and all levels
- QP qualification desirable but no required
- Should be highly motivated, flexible, and have excellent organisational and communication skills
- Excellent verbal and written communication skills
- Ability to priorities and balance work from multiple projects in parallel
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
Travel: Yes, 5 % of the Time