Associate Director, Quality Systems and Compliance

Serán BioScience • Bend, OR

20h • Onsite

About The Position

Serán is seeking an Associate Director, Quality Compliance to lead the Quality Compliance program and ensure ongoing adherence to applicable GxP regulations, client requirements, industry standards, and internal Quality Management System (QMS) requirements. The role owns inspection readiness and regulatory inspection management, client audit support, internal audit programs, supplier quality oversight, management review, quality metrics, and compliance monitoring. The Associate Director partners with Manufacturing, Quality Control, MSAT, Supply Chain, Regulatory Affairs, Engineering, Validation, and Quality Systems to foster a proactive quality culture and support sustainable compliance as the organization advances commercial manufacturing capabilities. The position is a key Quality leadership role during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement in cGMP compliance oversight.

The role leads and develops a high-performing Quality organization. It includes mentoring, coaching, and developing technical staff; providing timely performance evaluations; handling discipline in accordance with company policy; establishing departmental goals; ensuring staff maintain appropriate training and GMP qualifications; fostering quality ownership and continuous improvement; and overseeing departmental workflow.

The Associate Director leads the site's continuous inspection-readiness program, monitors regulatory expectations, assesses compliance gaps, and drives remediation and commercial-readiness initiatives. As Quality lead for health authority inspections, the role coordinates preparation, logistics, document management, responses, and follow-up on regulatory commitments. It manages customer audit preparation and support, risk-based internal audits, supplier qualification and monitoring, and related corrective and preventive actions.

The position coordinates site management reviews, compiles and presents quality-system performance data and compliance metrics, tracks actions, maintains compliance dashboards, and provides updates to site leadership. It also supports the site's Data Integrity Compliance Program, assesses computerized systems and data governance controls, participates in data-integrity investigations, facilitates quality risk assessments, and supports implementation of ICH Q9 principles.

Requirements

• Bachelor's degree in Life Sciences, Chemistry, Microbiology, Engineering, Pharmacy, or a related discipline.
• Minimum 8 years of pharmaceutical, biotechnology, medical device, or CDMO quality experience.
• Minimum 3 years of leadership experience within Quality Compliance, Quality Systems, or related quality functions.
• Experience supporting commercial manufacturing operations.
• Experience supporting FDA and/or EU regulatory inspections.
• Demonstrated knowledge of cGMP regulations and quality-system requirements.
• Experience with electronic Quality Management Systems (eQMS).
• Broad knowledge of FDA and international regulations related to cGMPs and commercial drug product manufacturing.
• Ability to organize and manage responsibilities independently with minimal oversight.
• Time and project management skills, including the ability to multitask and meet deadlines.
• Excellent verbal and written communication, interpersonal, and customer service skills.
• Strong organizational skills and attention to detail.
• Strong analytical and problem-solving skills.
• Strong supervisory and leadership skills, including the ability to prioritize and delegate tasks.
• Proficiency with Microsoft Office Suite or related software.
• Ability to meet the physical requirements of prolonged sitting or standing at a desk, working on a computer, and lifting up to 15 pounds at times.
• Consistent and predictable in-person attendance.
• Must be authorized to work for an employer in the U.S.; the employer is unable to sponsor or take over sponsorship of an employment visa.

Nice To Haves

• Advanced degree.

Responsibilities

• Lead and develop the Quality organization, including mentoring, coaching, performance reviews, staff training, GMP qualifications, departmental goals, and daily workflow.
• Lead the site's inspection-readiness program and maintain continuous readiness.
• Monitor regulatory expectations, assess their potential impact on the QMS, conduct compliance assessments, and drive remediation of inspection observations, compliance risks, and quality-system weaknesses.
• Serve as Quality lead for health authority inspections and coordinate preparation, logistics, document management, inspection support, responses, and regulatory commitment follow-up.
• Manage customer audit preparation and support, coordinate audit logistics and observation responses, track corrective and preventive actions, and trend observations for recurring risks.
• Develop and maintain the annual internal audit schedule and execute risk-based audits across relevant site functions.
• Communicate internal audit findings and recommendations to management and verify corrective-action implementation and effectiveness.
• Manage the Supplier Qualification Program and risk-based qualification and monitoring of suppliers, contract laboratories, consultants, contractors, and critical service providers.
• Review supplier performance metrics and trends, coordinate supplier audits and evaluations, support quality agreements and governance, and escalate supplier quality risks.
• Coordinate and facilitate Site Management Reviews, compile and present quality-system performance data and compliance metrics, and track management review actions through closure.
• Develop and maintain compliance dashboards and performance metrics, trend quality-system performance, and provide routine compliance updates to site leadership.
• Participate in developing annual quality objectives and monitor quality-system health and compliance indicators.
• Provide compliance guidance to cross-functional teams and promote risk-based decision-making.
• Support and maintain the site's Data Integrity Compliance Program; assess computerized systems and data governance controls; and participate in data-integrity investigations.
• Facilitate quality risk assessments related to compliance, product quality, and patient safety, and ensure risks are documented, mitigated, and escalated as appropriate.
• Support implementation of ICH Q9 principles within quality systems and operations.

Benefits

• Employees accrue over four weeks of paid time off annually.
• Employer retirement-account contributions begin after 90 days and require no employee match or vesting period.
• Multiple health plans are available with minimal employee contributions.
• Basic life and long-term disability coverage, with the option to increase or add coverage.
• Employee Assistance Program supporting employee wellbeing.
• Access to pet insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Director