Location: Fully Remote
Contract Duration: 12-Month Contract (Potential for Extension)
Job Overview:
We are seeking an experienced Quality Oversight to support quality and compliance activities within external manufacturing environments, including Contract Manufacturing Organizations (CMOs), contract labs, and raw material suppliers. This remote role requires occasional onsite presence (quarterly or as needed) and offers the opportunity to collaborate with cross-functional teams to ensure quality excellence.
The successful candidate will bring a strong quality mindset, broad experience in regulatory compliance, deviation management, and oversight of external manufacturing. This role is ideal for someone with a proven ability to work autonomously, lead quality initiatives, and navigate complex cross-functional environments.
Decision-Making Authority:
- Approve or reject deviations, CAPAs, change controls, and quality agreements.
- Provide the final decision on batch disposition (release or reject).
- Approve master batch records and raw material specifications.
- Define GMP-related strategies and positions in collaboration with key stakeholders.
Preferred Qualifications:
- 10+ years of experience in the biotech or pharmaceutical industry.
- Extensive experience with aseptic manufacturing facilities and regulatory compliance (HPRA and FDA).
- Strong expertise in deviation management, variation management, and GMP compliance.
- Familiarity with basic project management tools and principles.
- Proven ability to influence senior stakeholders, navigate complex situations, and manage timelines effectively.
- Knowledge of additional European languages is desirable but not essential.
- Exceptional problem-solving, critical thinking, and analytical skills.
- Experience in facilitating and driving cross-functional teams to achieve quality objectives.
Key Skills and Attributes:
- Ability to work autonomously with minimal supervision.
- Demonstrated experience managing quality systems in external manufacturing environments.
- Exceptional communication and stakeholder management skills, including experience influencing senior leadership.
- Strong project management and organizational skills.
- Familiarity with HPRA regulatory requirements and global GMP standards.
Ready to Apply? If you're passionate about quality systems, regulatory compliance, and driving excellence in external manufacturing environments, we encourage you to apply today!
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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