Director of Quality Control

Bend, Oregon /
Quality – Quality Control /
Full-time Exempt
Serán is searching for a Director of Quality Control to help ensure the highest level of cGMP production for the development and manufacturing within the pharmaceutical industry. This leadership position ensures that the Quality Control Analytical team is appropriately staffed, managed and resourced for product and raw material testing, and that these functions occur in a timely and efficient manner. Demonstrate leadership by taking ownership of the quality of delivery of data, protocols and reports, while maintaining compliance with applicable regulations and internal procedures. Requires team management, communication, and problem-solving skills.  Works directly with internal and external clients. In addition to a strong scientific background, the ideal candidate would have significant industry experience in a CDMO environment and Quality Control management.  

Supervisory Responsibilities

Recruit, interview, hire, and train new staff
Oversee the daily workflow of the department 
Provide constructive and timely performance evaluations  
Handle discipline and termination of employees in accordance with company policy
Perform other related duties as assigned
 
Duties and Responsibilities

Lead the Quality Control staff responsible for raw material and finished product release, stability, in-process, cleaning verification testing
Ensures that delivery of data is accurate and on-time
Owner of the Quality control metrics to assess overall and individual performance to ensure continuous improvement opportunities are being assessed and applied
Responsible for all systems, processes and resources for Quality Control support to Manufacturing Operations
Owner of Third-Party testing lab relationships
Collaborate with Manufacturing, AR&D, and Validation to ensure effective technology transfer from internal departments and external companies
Oversee Management team to ensure subject matter expertise is instilled to develop scientists’ motivation, education, efficiency, and performance management of individuals
Coordinate with Analytical R&D resources to optimize test methods and execution to streamline laboratory functions, operations and improve overall quality of such functions
Work with Quality Assurance Department to improve and sustain an effective and efficient quality management system. 
Oversee Specification and Stability Protocol Generation programs specification stability protocols, instrument qualification protocols, validation/qualification reports, SOPs, and CoAs
Responsible for the inventory and controls of glassware, consumables, samples, and standards including initiating change control activities for equipment
Responsible for GMP-compliant analytical laboratory and safe working environment
Responsibility for the coordination of compendial reviews for applicable material and substances

Required Skills and Abilities

Requires the ability to lead and motivate team members
Interest in developing and implementing new technologies 
Ability to work with other department heads to advance Company goals and initiatives
Ability to set priorities in a rapidly changing environment
Ability to work toward common goals by supporting, encouraging, and sharing information with colleagues, both internal and external
Technically capable of determining the root cause of a problem, offering potential solutions and working with others to correct problems
Ability to speak, write, listen, and present information in a logical and articulate manner to internal and external teams
Strong technical writing skills

Education and Experience

B.S. / M.S. in chemistry, pharmaceutical sciences, or related discipline with at least 5 years QC management experience and 10+ years related experience preferred (CDMO experience preferred) 
Demonstrated continued growth and responsibility in management and leadership experience
Expert level knowledge of drug product and raw material release and stability testing, industry expectations, methods, and systems for pharmaceutical products
Expert level knowledge of Industry Compendia (USP/Pharm EU, etc.)
Working knowledge of regulatory requirements including cGMP, FDA/EU, ICH and USP

Physical Requirements
       
Prolonged periods of sitting at a desk and working on a computer
Must be able to lift up to 15 pounds at time