Director of Quality Assurance

Director of Quality Assurance

The Director of 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. 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 Sern 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 companys 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

Required Skills and Abilities

Education and Experience

Physical Requirements

Visit https : / / www.seranbio.com / careers to learn more about company culture and the community of Bend, Oregon.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits Summary : Sern 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. Sern 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.

The Corporate Headquarters of Sern BioScience are located at 63047 Layton Ave, Bend, OR 97701

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