Quality Control Manager

The Quality Control department seeks an industry leader who demonstrates strong regulatory knowledge and GMP standards to oversee the IPC (In-Process) and Raw Materials program as leader and mentor within the department. In this role you will be responsible for improving, developing, implementing, and maintaining IPC (In-Process) and Raw Materials programs, and overall GMP compliance. Also, ensuring that all aspects of the quality control system at Serán BioScience are effectively established, implemented, and maintained in accordance with US-FDA, EU and other applicable regulations. Successful candidates will demonstrate experience in a supervisory role with dedication to fostering employee training, education, and a culture of safety and compliance within the Quality Organization.

Title and salary will be suited appropriately to the demonstrated skill and leadership capabilities of the chosen candidate. Those who meet the minimum qualifications are encouraged to apply to be assessed as Manager, Senior Manager, or Associate Director within the Quality Control Department.

• Recruits, interviews, hires, and trains new staff
• Oversees daily workflow of the department or direct reports
• Provides constructive and timely performance evaluations
• Handles discipline and termination of employee in accordance with company policy
• Performs other related duties as assigned

• Ensures that QC Systems and practices are developed and implemented in accordance with the requirements of GMP
• Represents the site in client interactions for all questions related to QC IPC testing and Raw Materials program
• Represents the site in audits and inspections related to QC IPC testing and Raw Materials programs
• Managing IPC and Raw Materials teams, acting as an advisor to team members when determining how to meet schedules or resolve technical problems
• Reviewing testing and laboratory records for accuracy and compliance with cGMP and company policies and procedures
• Developing Raw Materials programs and policies, ensuring sampling plans are up to date and executed as planned
• Hosting monthly trend meetings, sharing trend information with the site Quality Council, and identifying and escalating adverse trends
• Driving corrective and preventative actions, ensuring work is complete and the site remains in a state of control and compliance
• Leading environmental excursion investigations
• Monitoring QC resource capacity and providing feedback to QC management, program management, and production planners when capacity constraints exist
• Responsible in building and improving quality systems
• Control and execution of Deviations
• Corrective/Preventive Action (CAPA) plans
• Out-of-Specification/Out-of-Trend (OOS/OOT) results
• Update management on activities as well as provide input and recommendations as appropriate
• Developing and presenting KPI’s
• Preparation and support for internal audits
• All other duties as assigned

• Comprehensive knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development with prior experience through commercialization
• Proven experience developing budgets, monitoring, and escalating variances
• Experience and/or knowledge of process validation lifecycle approach for biological products is preferred
• Excellent knowledge of FDA/EU/ICH/CDN/AUS guidelines and inspections
• Maintain current knowledge of new technologies and potential applications
• Practical knowledge and understanding of implementing phase appropriate procedures and processes
• Excellent verbal and written communication skills
• Excellent interpersonal and customer service skills 
• Excellent organizational skills and attention to detail 
• Excellent time management skills with a proven ability to meet deadlines 
• Strong analytical and problem-solving skills
• Demonstrate integrity towards testing and reporting
• Strong supervisory and leadership skills
• Ability to prioritize tasks and to delegate them when appropriate
• Ability to function well in a high-paced and at times stressful environment
• Proficient with Microsoft Office Suite or related software

• BS in related scientific field, or equivalent work experience
• Thorough knowledge of GMP, SOPs and quality control processes
• Minimum of 5 years of experience in a supervisory or management position
• Minimum of 5 years of GMP experience
• Minimum of 5 years of Quality Control Chemistry experience for non-sterile formulations, such as dissolution and chromatography

• Prolonged periods of sitting at a desk and working on a computer
• Prolonged periods of sitting or standing in laboratory environment
• Must be able to lift up to 15 pounds at times
• Motor skills required for basic laboratory operations (pouring liquids, using utensils to transfer powders, visual assessments)

Compensation correlates to skills and experience presented by selected candidate. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Benefits Summary:

Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs. Serán fully funds employees and their household with dental, vision and one medical plan option. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing.