Director, Quality Control

Summary:

The Director of Quality Control (QC) is responsible for leading the Quality Control Unit (Microbiology & Chemistry) at the site and for providing analytical technical guidance to the various site functions. Responsibilities include but are not limited to overseeing total quality control activities, including testing of raw materials, intermediates, APIs and drug products, support to production, proper life-cycle of test methods (i.e. validation, transfer, review, approval, changes), OOS/OOT investigations, stability programs and compliance to the applicable compendial, regulatory and customer requirements.

The Director of Quality Control (QC) also ensures compliance of the laboratory operations to the most current data integrity requirements, drives continuous improvement activities and implementation of industry best practices in the QC laboratories to maximize efficiency while maintaining a high compliance level. The Director of Quality Control (QC) will interact with Curia internal and external customers.

Essential Duties and Responsibilities:

* Direct the Quality Control department. This includes, but is not limited to, scheduling and overseeing testing and operations of quality control team(s) responsible for samples and incoming, in-process and final product testing, coaching and mentoring QC analysts, supporting troubleshooting activities and investigations

* Ensure QC laboratory operations are cGMP compliant. This include but is not limited to overseeing of QC equipment qualification, maintenance and calibration programs, ensuring that QC procedures, practices and analytical methods are in compliance with the applicable compendial, regulatory and customer requirements and that QC investigations and thoroughly conducted

* Ensure that the QC functions are completed in accordance with the Company and governmental standards of safety and quality, and that all experimental documentation is complete and timely

* Partner with site stakeholders to achieve and maintain operational excellence, site quality compliance and a strong quality culture site-wide while maximizing efficiency of the QC laboratory to achieve the site business goals

* Collect, monitor and report quality control key performance indicators identifying and leading opportunity for improvements to achieve and maintain high quality, productivity and efficiency of the QC department

* Support Curia global quality and continuous improvements initiatives. Recommend and implement methods and techniques to increase the quality of products and/or service

* Oversee pharmaceutical analysis to support drug product manufacturing

* Mentor, coaches and provide in continuing training to QC personnel to increase the level of technical skills and compliance in the department

Supervisory Responsibilities:

This position has supervisory responsibilities.

Education and/or

Experience:

Required:

Bachelor's degree in Biology, Microbiology, Chemistry or related field. Minimum ten (10) years' experience in the pharmaceutical industry in drug substance or drug product manufacturing, including eight (8) years' experience in Quality Control. Minimum five (5) years' experience in a professional management role. Preferred:
Advanced degree in Biology, Microbiology, Chemistry or related field.

Computer

Skills:

Proficient in the use of MS Word, Excel, Outlook, and Access, as this individual will perform work within these systems on a routine basis.

Other

Skills and Abilities:

* Combined ability to mentor and coach individuals and ability to motivate teams to reach a common goal. Strong knowledge of cGMP regulations applicable to FDA regulations. Strong knowledge of QC techniques with proven ability to solve complex problems.

* Strategic thinking. Strong communication skills. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.

* Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to calculate figures and amounts such…