SUMMARY OF FUNCTIONS
The Director of Quality Control (QC) is responsible for leading the Quality Control unit at the site and for providing analytical technical guidance to the various site functions. This position's responsibilities include but are not limited to overseeing of the quality control activities, such as testing and releases of raw materials, intermediates and APIs, support to production, proper life-cycle of analytical 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 QC also ensures compliance of the analytical laboratories and 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 QC will interact with AMRI internal and external customers.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture.
In this role, you will:
- Direct the Quality Control department. This includes but is not limited to scheduling and overseeing in-process testing and release testing for all raw materials, intermediates and APIs, coaching and mentoring QC analysts, supporting analytical troubleshooting activities and investigations.
- Ensure QC laboratories, and operations are cGMP compliant. This include but is not limited to overseeing of analytical 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 data integrity principles are understood and implemented consistently in the QC laboratories and operations.
- Build a sense of customer confidence in departmental results. Effectively communicate with key stakeholders, including quality assurance, regulatory affairs, supply chain, and manufacturing making sure that their needs are met in a timely manner. Effectively communicate with AMRI customers when required to achieve and maintain a high level of customer satisfaction.
- 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 AMRI global quality and continuous improvements initiatives. Recommend and implement methods and techniques to increase the quality of products and/or service.
- Mentor, coaches and provide in continuing training to QC personnel to increase the level of technical skills and compliance in the department.
Education and/or Experience
- B.S./B.A. or M.S. degree in Analytical Chemistry or related field.
- A minimum of 10 years experience in the pharmaceutical industry in drug substance or drug product manufacturing, with at least 5 of those years being experience in Quality Control and at least 3 in a management role. Professional background not directly working in a QC function will also be considered given a relevant technical background and understanding of cGMP's and analytical chemistry.
- Strong knowledge of analytical techniques, such as HPLC, GC, PSD, and wet chemistry with proven ability to solve complex problems.
- Strong knowledge of cGMP regulations applicable to API manufacturers, including FDA regulations.
- Demonstrated experience in mentoring and coaching, with ability to motivate teams to reach a common goal.
- Strategic thinking and strong communication skills
- 15 years experience in the pharmaceutical industry in drug substance or drug product manufacturing, with at least 5 years experience in Quality Control and at least 5 years in a management role.
All interested applicants must apply online. AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness. Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.