Serán BioScience · 3 weeks ago
Director of Quality Assurance
Bend, Oregon
Full-time
Onsite
Director/Executive
10+ years expSerán BioScience is a company focused on quality and compliance in the pharmaceutical and biotechnology sectors. The Director of Quality Assurance will lead the QA department, ensuring compliance with GMP and regulatory standards while fostering a culture of quality and continuous improvement throughout the organization.
Biotechnology
No H1B
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
Qualification
Required
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; advanced degree is preferred
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
Benefits
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
Access to pet insurance
Company
Serán BioScience
At Serán, Our mission is to provide optimized drug development and manufacturing services for our clients, from discovery to the clinic.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Dan Smithey, PhD
President, CEO and Founder
Company data provided by crunchbase