Job Description We are now hiring a Director of Quality Systems and Compliance for our Westport site for a fixed term contract.
This person is responsibility for QA activities in support of all aspects of quality systems and compliance for commercial, clinical and development activities at the site.
The position is responsible for the implementing and managing an effective Quality Management System to ensure continued compliance with all global regulatory requirements.
The position holder will hold responsibility for providing competent, highly engaged staff to meet company and regulatory requirements.
Responsibilities: The QS and Compliance director is accountable for the management of the QS and compliance team and associated direct reports.
The position holder will drive and foster an ethos of continuous improvement, provide direction and input to all project activities to ensure appropriate design and risk management principles are captured from project initiation through to delivery.
The QS and Compliance director must show competence to drive forward and the skills to ensure that the function operates to meet/exceed defined targets.
The QS and Compliance director will work collaboratively with the Director of Quality Operations and site leadership team to ensure company business goals and objectives, strategic objectives, customer requirements and regulatory obligations as laid down by the FDA, EU and regional Ministries of Health are adhered to.
This person will manage and motivate a team through effective communication, coaching and influencing skills, hold performance conversations and maintain resources and staff capacity in line with business needs The Director of Quality Systems and Compliance will plan and implement the annual Global Quality Plan and site quality plan.
Evaluate and assess all global regulations and standards and ensure implementation is planned and executed and ensure that quality focus is maintained in site strategic initiatives.
This person will act as Quality Lead for Quality Systems and Compliance operations across the site and manage quality and compliance guidance to the quality function.
They will manage the site wide application of GMP requirements and the implementation and continuous improvement of the quality Management System and Policies.
This person will represent the company in all business unit Ministries of Health inspections, ensuring the site is audit ready.
Ensure any non-conformances and open commitments related to, are addressed.
Qualifications BS/MS in Scientific Discipline.
Must be qualified/recognized to hold a Qualified Person status.
10 + years experience in Pharma/Biotech industry.
5-7 years leadership experience in Quality or Quality related function.
In-depth and current knowledge of all relevant GxP and Quality System requirements (US, EU) for pharmaceutical and biotech, manufacturing and related activities.
Experience on leading and managing regulatory inspections with Global Health Authorities and of interacting with representing the company to Health Authorities, their agents, or related entities.
Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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