Head of QC Direct Materials Lab

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

The Opportunity

We are seeking an experienced Head of QC Direct Materials Lab to support direct material (raw material) testing. This role requires to ensure that the laboratory is maintained in a state of GMP compliance. Review and approve all documentation and ensure it is in accordance with GMP, standard operating procedures and reported results are accurate. Design QC programs and lead teams for continuous process improvements. Perform data analysis and trending. Conduct investigations on test failures and discrepancies. Improve existing methods. Responsibilities include:

• Daily Laboratory Management & Testing – Oversee all laboratory operations and testing activities to meet customer requirements, manage quality control processes, and ensure GMP compliance

• Staff Leadership & Development – Coach, train, and manage direct reports professionally and technically; identify development needs and provide performance feedback and career advancement opportunities

• Quality Assurance & Compliance – Review and approve all testing results and documentation; investigate test failures and discrepancies; support regulatory inspections and maintain compliance with industry standards

• Process Improvement & Technical Support – Troubleshoot analytical systems, write procedures and reports, recommend corrective/preventative actions, and lead implementation of new technologies to enhance efficiency and quality

• Safety & Culture – Promote a strong safety culture with active EHS participation, enforce policies and procedures, and foster a positive workplace where continuous improvement and employee well-being are prioritized

Who you are

• You possess a Bachelor’s Degree in Biology, Chemistry, Biochemistry or other relevant Life Science
  discipline with 5 years of relevant experience.

• You have 4 years of experience in chemical testing in quality control with at least 2 years of supervisory/lead experience

Knowledge, Skills, and Abilities

• Knowledge in manual and automated chemical and microbiological assays

• Excellent interpersonal, written and verbal communication skills

• Excellent decision making abilities

• Demonstrate strong leadership skills

• Ability to work in a fast pace environment

• Must be available on call to test and release samples as needed

• Experience in a Quality Control and cGMP environment

• Demonstrate strong presentation skills including the ability to prepare and deliver professional presentations to external business interests

• Effective coaching and employee monitoring skills

• Demonstrate excellent project management skills including the ability to plan, prioritize and complete work

• Ability to invest time, as required, expediting or completing assignments or projects

• Demonstrate strong spreadsheet, word processing and database skills necessary to process and present technical data in a clear and concise manner

• Ability to act independently and determine the methods and strategy for addressing and documenting issues which arise during chemical and microbiological testing

• Interpret and apply evolving regulatory and Quality standards

• Ability to establish strong working relationships and work in a team environment

Work Environment/Physical Demands/Safety Considerations

• Ability to Climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility

• May work in the clean room environment that requires that gowning and no make up or jewelry be worn

• May work in clean room where loud equipment is operating

• Work in office and laboratory environment

• Ability to Lift up to 30lbs

• Work with some hazardous materials and chemicals

• Ability to sit, stand and move within work space for extended periods

• Travel may be required up to 20% of the time

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $81,200.00 - $138,000.00 Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus