Principal Scientist - Quality Control Compliance

Principal Scientist - Quality Control Compliance

Location: Limerick, Ireland

Company: Leading Biopharma Company

About Us:

Join a pioneering biopharma company at the forefront of healthcare innovation in Limerick, Ireland. Our state-of-the-art facility, currently under construction, will be one of the most technically advanced manufacturing sites in the industry. With cutting-edge manufacturing technologies and advanced data analytics, this facility represents the future of biopharmaceutical production. We are dedicated to making a meaningful impact on global health, and we're looking for passionate individuals to join our mission.

Position Overview:

We are seeking a Principal Scientist - Quality Control Compliance to provide technical support for the compliance systems within our Quality Control Laboratory (QCL). This role is crucial to ensuring that our laboratory meets and exceeds global regulatory standards and maintains the highest levels of compliance during our facility's startup and beyond.

Key Responsibilities:

• Interpret regulatory requirements and global quality standards to develop and maintain local, digital-enabled systems, processes, and procedures.
• Monitor GMP and compendial compliance, ensuring adherence to internal and external requirements, including data integrity.
• Oversee the GMP readiness plan for our laboratories, ensuring a consistent and compliant approach across all lab operations during startup.
• Manage the entire lifecycle of analytical equipment, including oversight of third-party service providers and review of GMP documents associated with equipment qualification and calibration.
• Implement and maintain the QCL Training/Personnel Qualification Strategy, ensuring alignment with site policies and procedures.
• Serve as the QC SME for lab processes such as equipment qualification, lab investigations, and personnel qualification.
• Collaborate with central functions to develop and standardize QC processes and procedures.
• Lead and support change controls, deviations, root cause investigations, and implement CAPAs as necessary.
• Author and review key GMP documents, including SOPs, training materials, test methods, and validation master plans.
• Lead the QC inspection readiness program and participate in audits, focusing on the analytical aspects of cGMPs as defined by global regulatory authorities.
• Compile QC compliance metrics and provide recommendations to management.
• Provide ongoing education, coaching, and mentoring to QC personnel on the execution of quality systems.
• Act as the QC Quality Risk Management facilitator and SME.

Qualifications:

• Education: Bachelor’s Degree (Hons) in Analytical Chemistry, Chemistry/Biochemistry, Microbiology, Molecular Biology, or a related discipline.
• Experience: Minimum of 5 years of relevant GMP experience.
• Skills:
  • Strong technical expertise in analytical equipment lifecycle management and compendial requirements.
  • Deep understanding of data integrity requirements in a QC environment.
  • Proficiency with digital solutions for data, equipment, and laboratory management.
  • Experience with regulatory inspections.
  • Excellent written and oral communication skills.
  • Strong attention to detail and ability to work independently.
  • High learning agility, flexibility, and problem-solving abilities.

Additional Information:

• Travel: Candidates must be able to travel to US-based locations for familiarization and training as required. Duration and frequency will depend on experience levels and site goals.

Key Attributes for Success:

• Business Knowledge: High performance in delivering work, proactive in taking initiative, and capable of simplifying processes.
• Learning Agility: Ability to handle ambiguity, identify problems, and implement solutions effectively.
• Positive Influence: Trusted team member who follows through on actions and seeks feedback to improve.
• Relationship Building: Ability to establish and maintain key relationships across all levels in the organization.
• Leadership: Proven ability to influence peers and lead across functions.
• Communication: Strong written and oral communication skills, effective in both one-on-one and group situations.
• Decision-Making: Decisive, well-informed, and capable of gathering necessary information to arrive at the best solution.

Join us and be a part of a team that is shaping the future of biopharma manufacturing in Limerick!

How to Apply:

Interested candidates are invited to submit their resume and cover letter for consideration