Senior Compliance Specialist

West Pharmaceutical Services; Dublin; On-site; EUR 60,000 - 80,000; Full time

Job summary

A leading healthcare company located in Dublin is seeking a Senior Compliance Specialist. The role involves ensuring compliance with regulatory requirements, leading quality investigations, and supporting risk management. Candidates should possess a third-level qualification and have at least 5 years of experience in the medical device or pharmaceutical fields. The position offers a chance to work in a diverse and inclusive environment focused on patient care.

Qualifications

• 5+ years of experience in Medical Device or Pharmaceutical Manufacturing Environment.
• Thorough knowledge of ISO 13485 / 21 CFR Part 820 / EU GMP.
• Accredited lead auditor against recognized quality standards.

Responsibilities

• Ensure compliance with internal procedures and external regulatory requirements.
• Lead investigations related to Quality System issues.
• Support trend analysis and regulatory submissions.

Skills

Quality Systems Management

Regulatory Compliance

Risk Management

Lead Auditing

Communication Skills

Education

Third level qualification in Engineering/Quality/Science

Job description

Overview

Senior Compliance Specialist

Location: Dublin, Leinster, IE

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Responsibilities

• Understand and ensure compliance with internal procedures and external global regulatory requirements.
• Lead investigations related to Quality System related issues to ensure a thorough root cause, containment / corrective and preventive action is implemented.
• Support trend analysis and issuance of key reports to relevant departments.
• Support responses to Competent Authority queries.
• Support risk management, risk analysis and hazard analysis associated with complaint/post-market information.
• Actively participate as Lead Auditor in Internal & External Audit Schedule.
• Support of third party audits, control room set-up and management of general audit readiness throughout the business.
• Post Audit follow-up and reporting both internally & externally on action completion and verification of effectiveness to ensure audit findings are closed out satisfactory.
• DHR review of Medical Device to be conducted within the QMS.
• Responsible for the scheduling, data collection and co-presenting Management Review.
• Support and drive the improvement and culture for data integrity.
• Coach and drive a culture of compliance and continuous improvement.
• Develop processes and systems in line with best industry practice.
• Coordinate the monthly Quality Systems KPI reporting activity both internally and to corporate level.
• Support regulatory submissions as required.
• Interface with other departments on a regular basis to ensure adherence to West QMS, drive quality improvements and compile/relay trends and occurrences throughout the year.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training and regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Perform additional duties at the request of the direct supervisor.

Qualifications

• Must have a third level qualification in Engineering/Quality/Science.
• Level 8 qualification in a technical or related field plus 5 years of demonstrated experience in the administration of Quality Systems, or a combination of education and experience.
• Must have 5+ years’ work experience in Medical Device or Pharmaceutical Manufacturing Environment.
• A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 / 21 CFR Part 4/ EU GMP is essential. Knowledge of 21 CFR Part 210 / 211 would be considered an advantage.
• Knowledge of and experience in setting up and maintaining an effective QMS.
• Accredited lead auditor against recognised quality standards in support of internal and supplier audits
• Have experience in the facilitation of quality risk management coupled with a good working knowledge of ISO14971.
• Experience of hosting regulatory audits from either the European or US authorities
• Must have excellent communication and written skills

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to [e-mail]. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.