Quality and Regulatory Specialist
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Job Summary
Our team members are at the heart of everything we do. At Cencora we are united in our responsibility to create healthier futures and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
About the Role
This role is in support of BluePoint Laboratories a Cencora business offering a trusted source of generic pharmaceuticals.
This is a fantastic opportunity in a role that blends hands-on Quality Assurance with Regulatory Affairs giving you the chance to grow across both disciplines at the same time. The product portfolio is constantly evolving from pharmaceuticals and medical devices to exciting emerging areas like biosimilars so there is always something new to get involved in.
As a virtual operation you will collaborate with colleagues across multiple countries bringing real international exposure to your day-to-day work. A structured training plan is in place to set you up for success from day one.
Location: Little Island Cork
Shift Pattern: 39 hours per week Monday to Friday
Working Model: Hybrid 2 to 3 days on-site with the remainder from home
Key Responsibilities
Ensure ongoing compliance with cGMP Environmental Health and Safety regulations
Execute all Quality Management System activities including non-conformances deviations change control complaints CAPA document control and record retention
Manage and execute the finished product non-conformance process and support timely product release
Lead regulatory updates to product labelling ensuring compliant and timely product launches
Create and maintain National Drug Codes (NDC) Universal Product Codes (UPC) and Structured Product Labelling (SPL) for FDA submissions
Ensure company and product registration is maintained in all appropriate markets and with relevant regulatory agencies
Review and approve product labelling patient package inserts and associated documentation
Develop implement and maintain Standard Operating Procedures (SOPs)
Monitor Key Performance Indicators (KPIs) to track performance and identify opportunities for improvement
Stay current with evolving regulatory trends and requirements
Promote and maintain a safe healthy working environment
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Skills and Experience
Essential:
Minimum BSc in a scientific discipline (e.g. Chemistry Biology or related field)
At least 5 years experience in a Quality Assurance role within a cGMP environment
Experience with CAPAs deviations change control and other core QMS processes
Strong background in the pharmaceutical industry ideally within a manufacturing setting
Excellent written and verbal communication skills with strong attention to detail
Proven ability to work both independently and collaboratively across cross-functional teams
Strong problem-solving and critical thinking skills
Proficient in Microsoft Office (Excel Word) and Document Management Systems
Desirable:
Experience in Regulatory Affairs particularly around labelling and submissions
Familiarity with Medical Device regulations
Experience with Artwork review and/or Supplier Quality
Whats on Offer
Competitive salary
Annual performance bonus
Private healthcare coverage
Company pension scheme
A genuinely varied role combining Quality Assurance and Regulatory Affairs in one position
International exposure through a virtual cross-country working environment
Structured onboarding and training plan to support your success from day one
Opportunities to work on exciting new product areas including biosimilars
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full timeCencora is committed to providing equal employment opportunity without regard to race color religion sex sexual orientation gender identity genetic information national origin age disability veteran status or membership in any other class protected by federal state or local law.
The companys continued success depends on the full and effective utilization of qualified individuals. Therefore harassment is prohibited and all matters related to recruiting training compensation benefits promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Required Experience:
IC
About Company
Discover how Cencora delivers innovative cell and gene therapy solutions, enhancing patient access, affordability, and connectivity across treatment journeys.
