Senior Director Quality Control

FLSA Classification: Exempt/Salary 

Schedule: Monday – Friday; 8:00 am – 5:00 pm; Hybrid with 2-3 days On-Site or Fully Remote.   

Department: Global Quality Operations – Quality Control 

Reports to: Vice President, Global Quality Operations 

Supervisory responsibilities: Yes 

Location: Remote, with occasional travel to 13203 Murphy Road Suite 100 Stafford, TX 77477 

Position Summary/objective: 

The main role of the QC Senior Director is to provide strategic leadership for the QC Department. Key responsibilities include oversight and management of all aspects of quality control within Immatics, including but not limited to analytical, microbiological, and laboratory excellence; development and implementation of quality control standards including assurance of compliance with industry standards and regulations; and multi-departmental partnership including other Quality departments and all departments within CMC to drive improvements in quality, compliance, financial performance, employee development, customer satisfaction, and continuous improvement initiatives consistent with the corporate strategic plan.   

 
 Essential functions: 

• Establish a long-term strategy for Quality Control at Immatics. 

• Act as key member of Global Quality Operations leadership team. 

• Responsible for the QC Laboratory functions, both Analytical and Microbiology. 

• Responsible for managing, developing, and implementing compliant processes to ensure the highest level of product quality. 

• Ensure compliance with internal standards. 

• Ensure compliance with industry standards and regulations, staying current with any changes or updates. 

• Act as a role model for team members with respect to earning trust through own attendance, reliability, personal behaviors, transparent/frank communication, and execution of personal assignments. 

• Periodically review the suitability and effectiveness of the quality control system with the VP of Global Quality Operations. 

• Identify and manage continuous improvement projects that may span multiple teams or departments to achieve quality, reliability, and cost improvements. 

• Develop and ensure adherence to the budget. 

• Manage overall coaching, training, development, and succession plans for the QC department. 

• Responsible for identifying and implementing digital innovation for the QC laboratory. 

• Communicate frequently and regularly with team members assuring they have the information and tools to perform their functions. 

• Resolve conflict between team members if any arises – practice active listening of team members. 

• Set goals, measure achievement progress, and assist team members in successful execution of personal/team goals.  

• Coach and help develop team members into higher roles at Immatics if they so desire. 

 Secondary functions: 

• Deliver departmental and company objectives. 

• Coordinate the development and implementation of performance goals in QC. 

• Attract and retain key talent. 

Competencies: 

• Strong analytical and problem-solving skills. 

• Ability to work with multi-functional teams in a fast-paced setting. 

• Strong leadership skills and demonstrated success in managing a large team. 

• Ability to manage department budgets and staffing. 

• Understanding of new innovative laboratory concepts. 

• Result-driven with ideas to drive continuous improvement and process simplification with breakthrough solutions, including digital. 

Work environment: 

This is a sedentary position (at least 50% of time) in a typical office environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners, computers and other office equipment. Ability to sit, talk, walk, hear and communicate verbally and in writing is required. Occasional lifting of objects up to 25 lbs is expected.   

Physical demands: 

• Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly. 

• Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds. 

• Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.  

• Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or arms but may occur on the shoulder. 

• Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).  

• Pushing - Exerting force upon an object so that the object moves away from the object. 

• Pulling - Exerting force upon an object so that the object moves toward the force.  

• Sitting – remaining in a sitting position for at least 50% of the time. 

• Standing/Walking - remain on one's feet in an upright position at a workstation.  

• Stooping – occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.  

Travel required: 10% - 20% if remote; 10% if on-site 

 Required education and experience: 

• Bachelor’s degree in relevant scientific field. 

• 10+ years of biopharmaceutical experience with 5+ years in cell therapy and/or biologics. 

• 7+ years of management experience. 

• In-depth knowledge of industry standards and regulations related to quality control. 

• Knowledge of FDA, EMA, and PDA regulations, Good Data and Documentation Practices, and application of current Good Manufacturing Practices. 

Preferred education and experience: 

• Master’s degree or higher. 

• Experience running a large-scale, multi-function laboratory. 

• Experience with taking a company from Phase 3 to commercial production. 

• Knowledge of data analytics and Lean/Six Sigma concepts. 

Additional eligibility requirements: 

Ability to manage ambiguity and make decisions under stressful conditions. 

Work authorization/security clearance requirements: 

Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment 

Affirmative Action/EEO statement: 

Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical​​​ conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or ​expression, veteran status, or any other status protected under federal, state, or local law.” 

Other duties: