Director, Quality Control Job Description Template
Our company is looking for a Director, Quality Control to join our team.
Responsibilities:
- Participate in the completion of assigned qualification efforts as determined by the VP, Quality Control;
- Drive technical troubleshooting, operational improvements, and efficiency improvements while working within cGMP and global regulatory compliance;
- Assure all QC functions and testing are being performed according to FDA, EMA, ICH and other international regulations, as deemed necessary;
- Manage the work efforts of Quality Control resources ensuring work is completed on schedule and that they meet TCH standards;
- Participate or allocate resources to support the research and resolution of production incidents in a timely manner;
- Coordinate with other technology departments such as the EPMO, Development, DBA, Networking, Systems Support, IT Security, Change Control, and;
- Interacts with customers to identify opportunities to improve quality and establish feedback with manufacturing and development personnel;
- Other tasks assigned by management;
- Work with Formulation and Process Development teams to provide timely testing of development projects;
- Names and contact information of three references, or three letters of reference;
- Conduct peer-reviews of work products such as test plans, test scripts, and defect descriptions to ensure they meet TCH standards;
- Prioritize multiple assigned work streams to best optimize resources, completion dates, and equipment;
- Contribute to the development and maintenance of departmental policies and procedures, under the guidance of the VP, Quality Control;
- Leading customer interaction on all QC related projects including method development, method transfer/validation and routing testing updates;
- Manage and develop professional and technical skills and performance of department members.
Requirements:
- Understanding of Financial messaging protocols such as ISO 20022;
- Experience leading a team testing Web GUI and message based applications through manual and automated testing;
- Experience using the ALM (Quality Center) and UFT testing tools (or equivalent testing tools);
- Experience testing Linux based applications;
- 5+ years of software testing experience, 2+ years management of a software testing organization;
- Experience working in a highly regulated environment such as credit card or financial services;
- BS in Chemistry, Biochemistry, Microbiology, Biology or related life sciences field. Advanced level degree preferred;
- 5+ years previous QC management experience;
- Demonstrated ability to perform in a fast paced environment;
- Management of a team of 4 or more employees;
- Quality leadership experience working on cross-functional teams to harmonize operational, testing and compliance processes;
- Ability to manage multiple concurrent testing efforts;
- Prior experience in a CMO or dealing with CMOs preferred;
- Prior experience in leading a commercial, aseptic drug product quality control team is highly preferred;
- Must be able to walk or move about between locations.