BS/BA in chemistry or life science; Master's preferred.
At least 15 years in Pharmaceutical/Biotech industry; 8 years in Quality Operations in CDMO organizations.
Familiarity with CFR 21 and ICH guidelines regarding GMPs.
Previous management and project experience is mandatory.
Strong interpersonal and communication skills required, both written and oral.
Ability to influence others in challenging situations necessary.
Computer skills in MS Word, Excel, and Access desired.
Responsibilities
Develop and implement a robust Quality Management System for GMP activities.
Maintain the Quality Risk Management system effectively.
Ensure compliance with cGMP, Global Policies, and Health and Safety regulations.
Manage customer audits and handle Quality Agreements preparation and review.
Oversee inspections by FDA and other Health Authorities, ensuring inspection readiness.
Approve validation/qualification protocols and reports to meet international standards.
Lead and develop the quality assurance and Quality Control teams, providing feedback and coaching.
Release API intermediate and final batches as required.
Coordinate quality issues with other departments and customers.
Support site CAPEX and Operational Excellence initiatives.
Draft regulatory CMC strategies for API and drug products across various markets.
Report critical quality events to the Global Quality organization.
Benefits
Leadership role within a collaborative team environment.
Opportunity to influence quality standards across operations.
Engage in a diverse and dynamic pharmaceutical landscape.
Support in career growth with performance feedback and development opportunities.
Involvement in global regulatory strategy and compliance initiatives.
Full Job Description
Quality Unit Director
The Quality Unit Director is responsible for leading and continuously improving the site's Quality Management System, ensuring compliance with global regulatory requirements, and fostering a culture of quality excellence. The Quality Unit Director serves as a key member of the leadership team, partnering across functions to support business objectives, customer satisfaction, and the ongoing success of CordenPharma South Carolina.
Primary Responsibilities:
Develop and implement an effective Quality Management system for the development, manufacturing, testing and release of commercial and clinical API, by providing direction and guidance to all departments involved in GMP activities.
Implement and maintain a Quality Risk Management system.
Ensure that all activities are performed according to cGMP, Global Policies and Health and Safety rules.
Manage customer audits, prepare, review and approve Quality Agreements
Manage FDA and other Health Authorities inspections, including the preparation and execution of the inspection readiness program.
Ensure that all validation/qualification activities are executed according to international standards. This includes the approval of validation/qualification protocol and reports as needed.
Hire, coach and motivate the quality assurance and Quality Control staff and/or functions. Responsible for providing regular performance feedback, development opportunities.
Responsible for the release of API intermediate and final API batches.
Communicate and coordinate with other departments and customers as required for quality related issues.
Support the site in CAPEX and Operational Excellence initiatives.
Responsible for elaboration of regulatory CMC strategies to support development and lifecycle of APIs and drug products in USA, EU, emerging countries, and ROW.
Escalate to Global Quality organization critical events as per global procedure.
Help to draft and update annually DMF documents.
Qualifications:
The successful candidate must be able to work on multiple projects with a minimum of supervision and meet established timelines.
Qualified candidate should have a BS/BA in chemistry or life science. Master's degree preferred.
A minimum of 15 years' experience in Pharmaceutical, Biotech, or related industry required with at least 8 years in Quality Operations in CDMO organizations.
Be familiar with both CFR 21 and ICH guidelines in regard to GMPs'.
Previous management and project experience is required.
Requires the ability to change the thinking of or gain acceptance of others in sensitive situations.
Computer skills in MS Word, EXCEL, and Access are desirable.
Must possess strong interpersonal and communication (written and oral) skills.
