Manager, Quality Control

Manager, Quality Control, Camarillo, CA

Build your future at Curia, where our work has the power to save lives 

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

We proudly offer

• Generous benefit options (eligible first day of employment) 
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities 
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more! 

Summary:

The Manager of Quality Control is responsible for overseeing all operations within the Quality Control Laboratory. This role encompasses a wide range of duties, including personnel management (hiring, conducting performance reviews, managing performance, scheduling, etc.), budget preparation and management, and ensuring the lab is audit-ready for both regulatory bodies and customers. The Manager will also be responsible for developing and maintaining departmental metrics, representing the department in various internal and external meetings, and collaborating with both internal stakeholders and external customers to deliver exceptional service. Additionally, this position involves fostering a culture of continuous improvement, ensuring compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), and leading initiatives to enhance laboratory efficiency and effectiveness.

Essential Duties and Responsibilities:

• Complete tasks as required (in a timely manner), compliant with cGMP, regulatory and corporate requirements and conform to Health, Safety & Environmental responsibilities.   
• Mentor chemists and analysts
• Write, review, revise and approve:
  • Standard Operating Procedures (i.e. Laboratory Procedures) 
  • Project Progress Reports
  • Project Timelines
  • Acceptance Methods
  • Test Data (Summary Results)
• Conduct and appropriately document laboratory investigations 
• Write, review and direct the execution of analytical protocols
• Manage computer system validation (CSV) activities for analytical equipment/instruments   
• Demonstrate success in technical proficiency, scientific creativity, independent thought, and collaboration with others.
• Demonstrate analytical problem solving skills
• Conduct data analysis using a wide range of scientific and statistical tools
• Troubleshoot and resolve complex issues 
• Demonstrate high ethical standards
• Possess analytical instrument trouble shooting skills
• Demonstrate excellent oral and written communication skills
• Demonstrate both multi-tasking ability and the ability to effectively prioritize projects
• Demonstrate the ability to observe and communicate trends and develop “continuous improvement” plans. 
• Act as a technical liaison with customers to define objectives of projects and provide written/verbal reports on progress.
• Possess analytical instrument repair knowledge and ability. 
• Read/interpret SOPs to ensure compliance
• Maintain a robust training program designed to demonstrate proficiency in analytical techniques. MEnsure analysts maintain up to date trainings
• Other duties as assigned

Education and/or Experience:   

• Bachelor’s degree in in Science, Chemistry, Biology or related field of study
• Minimum of five (5) years in Analytical Chemistry, Quality Assurance or Regulatory Compliance Management
• Minimum of two (2) years in a leadership role 
• Minimum of five (5) years in an aseptic/sterile product facility, preferred

Supervisory Responsibilities: This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. This role also involves fostering a positive work environment, providing guidance and support to your team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.

Language Skills: The ideal candidate should have the ability to read and interpret various documents. These documents include safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, the candidate should possess strong written and verbal communication skills. They shoul