Quality Assurance Compliance Manager

This is a leadership role with responsibility for the site compliance programme, quality systems performance and the development of a team of quality professionals. The successful candidate will provide technical leadership, support inspection readiness and act as a key quality systems subject matter expert for the site.

Responsibilities

• Lead the Quality Assurance aspects of the site quality system, including Management Review, Corrective and Preventive Action (CAPA), Change Management, Document Management, Complaints, Training, Inspection Readiness and Management, the Self-Inspection Programme, Supplier Management, and Quality and Technical Agreements.
• Develop and manage the quality system to ensure compliance across all departments and personnel with US FDA, ICH, EudraLex and AbbVie requirements and standards.
• Prepare and maintain the Site Master File, Quality Manual and Quality Plans.
• Ensure that products manufactured at AbbVie meet the requirements of customers, regulatory authorities and the company.
• Develop and maintain quality system performance measures and report results through management review and quality performance meetings.
• Liaise with AbbVie quality and compliance colleagues, the FDA, the Health Products Regulatory Authority (HPRA) and other regulatory bodies.
• Lead regulatory inspection and corporate audit preparation for the assigned area, present technical data to stakeholders and ensure significant quality events are escalated to site quality leadership.
• Identify and lead continuous improvement and simplification initiatives, including the delivery of new quality systems initiatives.
• Champion and support the adoption of AI-enabled tools to drive process optimisation, simplification, and continuous improvement initiatives.
• Provide technical leadership and quality systems guidance to functional areas, collaborating with key stakeholders to support site goals and objectives.
• Lead, manage and develop quality professionals and direct reports within the QA Compliance group, including goal setting, performance reviews, development plans and talent management.
• Prioritise team activities in line with business needs, support timely closure of quality issues and promote a Right First Time approach.
• Act as delegate for the Associate Director, QA Compliance, as required.
• Adhere to and support all Environment, Health and Safety standards, procedures and policies.

Qualifications

• A third-level qualification in a science discipline and at least 8 years' experience in the healthcare or pharmaceutical industry.
• A minimum of two years of people management experience.
• Demonstrated audit and inspection management experience.
• Excellent understanding of current Good Manufacturing Practice (cGMP) and manufacturing operations.
• Qualified Person (QP) eligibility is desirable.

Knowledge, skills and behaviours

• Deep knowledge of GMP requirements and regulations, with the expertise to assess day-to-day quality issues and make sound quality decisions while maintaining patient focus and safeguarding company reputation.
• Strong problem-solving, analytical and decision-making skills, with the ability to propose and implement effective solutions.
• High attention to detail, accuracy and compliance, combined with the ability to manage priorities in line with business demands.
• Results-focused approach, with integrity, personal accountability, initiative and the tenacity to bring issues to closure.
• Strong verbal and written communication, interpersonal, influencing and leadership skills.
• Proficiency in Microsoft Office. Experience with Veeva Vault, TrackWise and ComplianceWire is desirable.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html