Reporting directly to the Site Quality Leader, the Manager of Quality Systems & Compliance is responsible for the maintenance and execution of the Greenville Quality System for the Solutions Facility. In addition, the role is responsible for site compliance to applicable regulations and standards.
Oversee and ensure the proper execution of key quality system elements such as records management, document control, change management, CAPA, regulatory and notified body audits, internal audits, supplier audits, training, regulatory management, management review etc.
Provide direction/leadership to Greenville Operations on cGMP for both Drug and Medical Device products and other compliance requirements.
Ensure that the entire Greenville operation maintains compliance with associated regulations from the site standards list and industry best practices.
Conduct and facilitate internal, regulatory and third-party inspections for the site, including the drafting of response communication from post-inspection follow up, as required.
Interface with outside regulatory and legal authorities as appropriate.
Review, revise and approve procedures and specifications, and then communicates and implements them with the applicable department.
Manage the training program for the site.
Act as the site quality lead for data integrity initiatives.
Work directly with the Site Quality Leader to deploy Regional Quality initiatives to the site, conduct gap assessments as needed and provide key input into the development of such initiatives.
Oversee the performance of department staff. Establish, manage and monitor departmental budget and spending against stated variances. Establish, communicate and execute against strategic quality and site objectives.
Identify, evaluate, select and implement against continuous improvement and compliance initiatives.
Role has budget responsibility for department spending.
Size of Team: 9+ personnel.
Responsibility is limited to Greenville Location
Minimum of a B.S. degree, scientific or engineering degree.
Certifications preferred: CQA, CQE, CQM.
10+ years of experience managing quality systems or directly associated with manufacturing or manufacturing quality in a sterile dosage pharmaceutical or medical device facility. (i.e., 21CFR211, 21CFR820, ISO 9001, ISO 13485).
Experience in leading, conducting and writing investigations.
Experience in preparation and execution of GMP regulatory inspections.