Serán BioScience
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Director of Quality Assurance
role at
Serán BioScience
The Director of Quality Assurance plays an integral role in fostering a culture of quality, efficiency, and excellence. This position provides strategic direction and guidance for the Quality Assurance functions, ensuring end‑to‑end harmonization of quality processes including risk and GMP core management, and regulatory compliance with worldwide requirements. The director also ensures that Quality operates in compliance with internal quality system procedures, mitigates identified compliance and quality risks throughout the product life cycle, and oversees compliance with cGMP, FDA, and EU guidelines.
Responsibilities
Identify and eliminate risk to continuously improve customer satisfaction and product reliability.
Lead and steer the QA Department, including hiring, mentoring, performance evaluation, and employee discipline in accordance with company policy.
Implement and continuously improve the company’s quality systems and facility validation.
Create and maintain product quality documentation systems by writing and updating procedures.
Lead Quality System improvements, investigations, CAPAs, change management, document control, validation, and auditing.
Oversee site activities, ensuring compliance with cGMP, FDA, and EU guidelines.
Author, review, and approve SOPs, batch production and QC records, certificates of analysis, method validations, and equipment qualifications.
Support internal audits, client audits, and regulatory inspections.
Provide support and oversight of Quality Management Review meetings.
Maintain documentation including URS, functional and design specifications, testing protocols, change controls, and risk assessments.
Enforce quality assurance policies and government requirements to maintain product quality.
Collaborate with management to develop new product and engineering designs and manufacturing and training methods.
Prepare product and process quality reports by collecting, analyzing, and summarizing information and trends.
Define and maintain a strong people management, training, and engagement culture to ensure a high and continuously improving right‑first‑time rate in manufacturing and QC.
Manage the QA budget, ensuring resources are allocated appropriately and all projects are completed on time and within budget.
Assume additional duties as assigned, with scope increasing to align with company initiatives.
Required Skills and Abilities
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 FDA and EU authorities.
Ability to influence diverse stakeholders and drive accountability and decision‑making cross‑functionally.
Demonstrated ability to partner with 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.
Proficiency in Microsoft Office Suite or related software.
Strong analytical and problem‑solving skills.
Proven ability to lead organizations and delegate appropriately.
Ability to prioritize tasks.
Education and Experience
Bachelor’s degree in a scientific discipline (advanced degree preferred).
Minimum of 10 years of GMP and Quality experience in the pharmaceutical or biotechnology industry.
Minimum of 5 years in a QA management role.
Physical Requirements
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 Summary 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 employee wellbeing, along with access to pet insurance.
Bend, OR $86,000.00–$141,000.00
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Director of Quality Assurance
role at
Serán BioScience
The Director of Quality Assurance plays an integral role in fostering a culture of quality, efficiency, and excellence. This position provides strategic direction and guidance for the Quality Assurance functions, ensuring end‑to‑end harmonization of quality processes including risk and GMP core management, and regulatory compliance with worldwide requirements. The director also ensures that Quality operates in compliance with internal quality system procedures, mitigates identified compliance and quality risks throughout the product life cycle, and oversees compliance with cGMP, FDA, and EU guidelines.
Responsibilities
Identify and eliminate risk to continuously improve customer satisfaction and product reliability.
Lead and steer the QA Department, including hiring, mentoring, performance evaluation, and employee discipline in accordance with company policy.
Implement and continuously improve the company’s quality systems and facility validation.
Create and maintain product quality documentation systems by writing and updating procedures.
Lead Quality System improvements, investigations, CAPAs, change management, document control, validation, and auditing.
Oversee site activities, ensuring compliance with cGMP, FDA, and EU guidelines.
Author, review, and approve SOPs, batch production and QC records, certificates of analysis, method validations, and equipment qualifications.
Support internal audits, client audits, and regulatory inspections.
Provide support and oversight of Quality Management Review meetings.
Maintain documentation including URS, functional and design specifications, testing protocols, change controls, and risk assessments.
Enforce quality assurance policies and government requirements to maintain product quality.
Collaborate with management to develop new product and engineering designs and manufacturing and training methods.
Prepare product and process quality reports by collecting, analyzing, and summarizing information and trends.
Define and maintain a strong people management, training, and engagement culture to ensure a high and continuously improving right‑first‑time rate in manufacturing and QC.
Manage the QA budget, ensuring resources are allocated appropriately and all projects are completed on time and within budget.
Assume additional duties as assigned, with scope increasing to align with company initiatives.
Required Skills and Abilities
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 FDA and EU authorities.
Ability to influence diverse stakeholders and drive accountability and decision‑making cross‑functionally.
Demonstrated ability to partner with 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.
Proficiency in Microsoft Office Suite or related software.
Strong analytical and problem‑solving skills.
Proven ability to lead organizations and delegate appropriately.
Ability to prioritize tasks.
Education and Experience
Bachelor’s degree in a scientific discipline (advanced degree preferred).
Minimum of 10 years of GMP and Quality experience in the pharmaceutical or biotechnology industry.
Minimum of 5 years in a QA management role.
Physical Requirements
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 Summary 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 employee wellbeing, along with access to pet insurance.
Bend, OR $86,000.00–$141,000.00
#J-18808-Ljbffr