Associate Director, Quality Systems and Compliance

Serán BioScience • Bend, OR

2d • 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 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 sustainable compliance as the organization advances commercial manufacturing capabilities. The position is a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement in cGMP compliance oversight.

The role leads and develops the Quality organization, sets departmental goals, oversees daily workflow, mentors and evaluates staff, and ensures appropriate training and GMP qualifications. It also leads inspection readiness and audit programs; oversees supplier qualification and monitoring; coordinates site management reviews and compliance metrics; supports data integrity and computerized-systems assessments; and promotes risk-based decision-making and implementation of ICH Q9 principles.

Requirements

• Bachelor's degree in Life Sciences, Chemistry, Microbiology, Engineering, Pharmacy, or a related discipline.
• At least 8 years of pharmaceutical, biotechnology, medical device, or CDMO quality experience.
• At least 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 work independently with minimal oversight, prioritize and delegate tasks, multitask, and meet deadlines.
• Time and project management skills.
• Excellent verbal and written communication, interpersonal, customer service, organizational, and attention-to-detail skills.
• Strong analytical, problem-solving, supervisory, and leadership skills.
• Proficiency with Microsoft Office Suite or related software.
• Consistent and predictable in-person attendance.
• Must be authorized to work for an employer in the United States; the company cannot sponsor or take over sponsorship of an employment visa.

Nice To Haves

• Advanced degree.

Responsibilities

• Lead and develop a high-performing Quality organization; provide mentoring, coaching, professional development, timely performance evaluations, and discipline in accordance with company policy.
• Establish departmental goals aligned with quality and operational objectives, oversee daily departmental workflow, and ensure staff maintain appropriate training and GMP qualifications.
• Lead the site's inspection readiness program and maintain continuous readiness.
• Monitor evolving regulatory expectations, assess their impact on the Quality Management System, conduct compliance assessments, identify gaps, and drive remediation and compliance initiatives.
• Serve as the Quality lead for health authority inspections; coordinate preparation, logistics, document management, inspection support, and response activities; track regulatory commitments through completion and effectiveness verification.
• Manage customer audit preparation and support, coordinate audit logistics and observation responses, facilitate client quality due diligence and qualification audits, and track corrective and preventive actions.
• Develop and maintain the annual internal audit schedule; execute risk-based audits across relevant site functions; communicate findings to management and verify corrective-action implementation and effectiveness.
• Manage the Supplier Qualification Program and risk-based qualification and monitoring of suppliers and service providers; review performance trends, coordinate audits and evaluations, support quality agreements, and escalate supplier-related risks.
• Coordinate and facilitate Site Management Review processes; compile and present quality-system performance data and compliance metrics; track management-review actions; and maintain compliance dashboards and performance metrics.
• Provide routine compliance updates to site leadership, participate in annual quality objective development, monitor quality-system health, and identify trends or risks requiring escalation.
• Support and maintain the site's Data Integrity Compliance Program; assess computerized systems and data-governance controls; and participate in investigations involving data-integrity concerns.
• Facilitate quality risk assessments related to compliance, product quality, and patient safety; ensure risks are documented, mitigated, and escalated as appropriate; and support implementation of ICH Q9 principles.
• Provide compliance guidance to cross-functional teams and promote risk-based decision-making throughout the organization.

Benefits

• Over four weeks of paid time off accrued annually.
• Employer retirement-account contributions begin after 90 days and require no employee match or vesting period.
• Various health plans 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: Senior