Director of Commercial Quality Assurance

Serán BioScience • Bend, OR

5d • Onsite

About The Position

The Director of Commercial Quality Assurance plays an integral role in fostering a culture of quality, efficiency, and excellence, ensuring that quality and compliance are integrated into the day-to-day operations and long-term Quality strategy. The focus of this position will be to support the Commercial Manufacturing Facility that is currently underway, giving the selected candidate to truly be a visionary leader in the development and implementation of the Commercial Quality Assurance program. This position will provide strategic direction and guidance for the Quality Assurance functions to assure end-to-end harmonization of quality processes including risk and GMP core management, and regulatory compliance with worldwide requirements. The position is also responsible for ensuring that Quality operates in compliance within internal quality system procedures, mitigation of identified compliance and quality risks throughout product life cycle from development to commercialization for the products manufactured at Serán BioScience. Duties and Responsibilities Identifies and eliminates risk to continuously improve customer satisfaction and product reliability Leads and steers Quality Assurance (QA) Department, including hires and mentors QA personnel, provides constructive and timely performance evaluations, and handles discipline of employees in accordance with company policy Leads implementation and continuous improvement of the company’s quality systems and facility validation Creates product quality documentation system by writing and updating quality assurance procedures Leads Quality System improvements, Investigations, CAPAs, Change Management, Document Control, Validation, and Auditing Responsible for oversight of site activities, assuring that products are manufactured in compliance with cGMP, FDA, and EU guidelines Documents authorship, reviews, and approves of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications Supports internal audits, client audits and regulatory inspections Provides support and oversight of Quality Management Review meetings Oversight of a broad range of documentation including, but not limited to User Requirements Specifications (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Change Controls, and Risk Assessments Maintains product quality by enforcing quality assurance policies and procedures and government requirements Collaborates with other members of management to develop new product and engineering designs and manufacturing and training methods Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends Defines and maintains a strong people management, training, and engagement culture to ensure a high and constantly improving right first-time rate in manufacturing and QC Manages the QA budget to ensure that resources are allocated appropriately and that all projects are completed on time and within budget Responsibilities may increase in scope to align with company initiatives Other related duties as assigned

Requirements

• General knowledge of aseptic manufacturing processes
• Expert knowledge of GMP guidelines and Quality expectations for preclinical and clinical phase programs
• In-depth understanding and application of cGMP principles, concepts, practices, and standards
• Experience with regulatory inspections by the FDA and EU authorities
• Ability to influence diverse stakeholders and drive accountability and decision-making cross functionally
• Demonstrated ability to partner with other functional groups to achieve business objectives
• Broad knowledge of FDA and international regulations related to GMPs and Pharmaceuticals
• Experience organizing and managing work responsibilities while working independently with minimal oversight
• Time and project management skills with the ability to multi-task and meet deadlines
• Excellent verbal and written communication skills
• Excellent organizational skills and attention to detail
• Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside of the company
• Accepts feedback from a variety of sources and constructively manages conflict
• Strong analytical and problem-solving skills
• Proven ability to lead organizations
• Ability to prioritize tasks and to delegate when appropriate
• Proficient with Microsoft Office Suite or related software
• Bachelor’s degree in a scientific discipline
• Requires a minimum of 10 years of GMP and Quality experience in the Pharmaceutical or Biotechnology industry
• Requires a minimum of 5 years in a QA management role
• Prolonged periods of sitting or standing at a desk and working on a computer
• Must be able to lift up to 15 pounds at a time
• Adheres to consistent and predictable in-person attendance

Nice To Haves

• advanced degree is preferred

Responsibilities

• Identifies and eliminates risk to continuously improve customer satisfaction and product reliability
• Leads and steers Quality Assurance (QA) Department, including hires and mentors QA personnel, provides constructive and timely performance evaluations, and handles discipline of employees in accordance with company policy
• Leads implementation and continuous improvement of the company’s quality systems and facility validation
• Creates product quality documentation system by writing and updating quality assurance procedures
• Leads Quality System improvements, Investigations, CAPAs, Change Management, Document Control, Validation, and Auditing
• Responsible for oversight of site activities, assuring that products are manufactured in compliance with cGMP, FDA, and EU guidelines
• Documents authorship, reviews, and approves of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications
• Supports internal audits, client audits and regulatory inspections
• Provides support and oversight of Quality Management Review meetings
• Oversight of a broad range of documentation including, but not limited to User Requirements Specifications (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Change Controls, and Risk Assessments
• Maintains product quality by enforcing quality assurance policies and procedures and government requirements
• Collaborates with other members of management to develop new product and engineering designs and manufacturing and training methods
• Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends
• Defines and maintains a strong people management, training, and engagement culture to ensure a high and constantly improving right first-time rate in manufacturing and QC
• Manages the QA budget to ensure that resources are allocated appropriately and that all projects are completed on time and within budget
• Responsibilities may increase in scope to align with company initiatives
• Other related duties as assigned

Benefits

• 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 with minimal employee contributions.
• 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, along with access to pet insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 251-500 employees