Senior Compliance Specialist

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There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. West supports the physical, mental, emotional and financial health of our team members and their families.

At West, we're a dedicated team connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our work delivers thousands of life-saving and life-enhancing injectable medicines to millions of patients daily. A name started our story; how will yours help write our future?

West is committed to sustainability and giving back to the communities where we live and work.

The primary responsibilities of the Senior Quality Specialist involve systems oversight with a customer focus across Quality Management Systems, relaying trends to Senior Management, and implementing improvements proactively. Coordinate activities to ensure timely closure of internal/external quality issues/projects and drive continuous improvement initiatives, including mentoring the business with respect to relevant quality tools. Liaise with company-wide departments to ensure internal system compliance and that customer specifications are met, and coach a culture of compliance and continuous improvement. Ensure site compliance to corporate, regulatory and customer quality standards. Reports directly to the Quality Compliance Manager.

• 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.
• Working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 / 21 CFR Part 4 / EU GMP. Knowledge of 21 CFR Part 210 / 211 is 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.
• Experience in facilitating quality risk management with knowledge of ISO14971.
• Experience hosting regulatory audits from European or US authorities.
• Excellent communication and written skills.

• Understand and ensure compliance with internal procedures and external global regulatory requirements.
• Lead investigations related to Quality System issues to ensure thorough root cause analysis, containment/corrective and preventive actions.
• 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 related to complaints/post-market information.
• Act as Lead Auditor in Internal & External Audit schedules.
• Support third party audits, control room setup and audit readiness throughout the business.
• Post-audit follow-up and reporting on action completion and effectiveness to close out findings satisfactorily.
• DHR review of Medical Device within the QMS.
• Schedule, data collection and co-presentation of Management Review.
• Support and drive improvement and culture for data integrity.
• Coach and drive a culture of compliance and continuous improvement.
• Develop processes and systems aligned with best industry practice.
• Coordinate monthly Quality Systems KPI reporting internally and to corporate level.
• Support regulatory submissions as required.
• Interface with other departments to ensure adherence to West QMS and drive quality improvements.
• Act in accordance with the company's Guiding Principles and Code of Conduct.
• Compliance with Environmental, Health and Safety requirements and company policies.
• Perform additional duties as requested by the direct supervisor.

West is an equal opportunity employer and we value diversity. 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 require accommodations to apply, please email Where permitted by law, employment is contingent upon background screening and/or a pre-employment drug screening.