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Associate Director, Quality Systems and Compliance

United States·BendFull-time Exempt

Legal & ComplianceCompliance

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Quick Summary

Overview

Serán is seeking an Associate Director, Quality Compliance who will be responsible for leading the Quality Compliance program to ensure ongoing adherence to applicable GxP regulations,

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Legal & ComplianceCompliance

Serán is seeking an Associate Director, Quality Compliance who will be responsible for leading the Quality Compliance program to ensure ongoing adherence to applicable GxP regulations, client requirements, industry standards, and internal Quality Management System (QMS) requirements. This role serves as the primary owner of inspection readiness, regulatory inspection management, client audit support, internal audit programs, supplier quality oversight, management review, quality metrics, and compliance monitoring activities.

The Associate Director partners closely with Manufacturing, Quality Control, MSAT, Supply Chain, Regulatory Affairs, Engineering, Validation, and Quality Systems to foster a proactive quality culture and ensure sustainable compliance as the organization advances commercial manufacturing capabilities. This position serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to cGMP compliance oversight.

Leads and develops a high-performing Quality organization
Provides mentoring, coaching, and professional development for technical staff; provides constructive and timely performance evaluations, and handles discipline of employees in accordance with company policy
Establish clear departmental goals aligned with organizational quality and operational objectives
Conducts performance reviews and ensure staff maintain appropriate training and GMP qualifications
Fosters a culture of quality ownership, compliance, and continuous improvement
Oversees daily workflow of the department

Lead the site's inspection readiness program and maintain a state of continuous readiness.

Monitor evolving regulatory expectations and assess potential impacts to the Quality Management System.

Conduct routine compliance assessments to identify gaps and opportunities for improvement.

Drive remediation activities associated with inspection observations, compliance risks, and quality system weaknesses.

Support implementation of compliance initiatives necessary to maintain commercial manufacturing readiness.

Serve as Quality lead for health authority inspections.

Coordinate inspection preparation activities across all functional areas.

Lead inspection logistics, document management, response coordination, and inspection support activities.

Facilitate timely and effective responses to regulatory observations.

Track regulatory commitments through completion and effectiveness verification.

Manage customer audit preparation and support activities.

Partner with clients to facilitate quality due diligence, qualification, and surveillance audits.

Coordinate audit logistics and observation responses.

Track completion of corrective and preventive actions resulting from client audits.

Trend audit observations to identify recurring compliance risks.

Develop and maintain the annual internal audit schedule.

Execute risk-based internal audits across manufacturing, laboratory, warehouse, engineering, supplier quality, and quality systems functions.

Assess effectiveness of quality system implementation and compliance.

Communicate audit findings and recommendations to management.

Verify implementation and effectiveness of corrective actions.

Manage the Supplier Qualification Program.

Ensure risk-based qualification and monitoring of suppliers, contract laboratories, consultants, contractors, and critical service providers.

Review supplier performance metrics and quality trends.

Coordinate supplier audits and periodic evaluations.

Support quality agreements and supplier quality governance activities.

Escalate supplier-related quality risks to management.

Coordinate and facilitate Site Management Review processes.

Compile quality system performance data and compliance metrics.

Present key compliance trends, risks, and quality indicators to leadership.

Track management review actions through closure.

Ensure management review activities support executive decision-making and resource planning.

Develop and maintain compliance dashboards and performance metrics.

Trend quality system performance and identify emerging compliance risks.

Monitor key performance and compliance indicators including.

Provide routine compliance updates to site leadership.

Participate in development of annual quality objectives.

Monitor quality system health and identify compliance trends requiring escalation.

Provide compliance guidance to cross-functional teams.

Support and maintain the site’s Data Integrity Compliance Program

Provide assessments of computerized systems and data governance controls

Participate in investigations involving data integrity concerns

Promote risk-based decision making throughout the organization.

Facilitate quality risk assessments related to compliance, product quality, and patient safety.

Ensure risks are appropriately documented, mitigated, and escalated when necessary.

Support implementation of ICH Q9 principles within quality systems and operations.

Broad knowledge of FDA and international regulations related to cGMPs and commercial drug product manufacturing.

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 interpersonal and customer service skills.

Excellent organizational skills and attention to detail.

Strong analytical and problem-solving skills.

Strong supervisory and leadership skills.

Ability to prioritize tasks and to delegate them when appropriate.

Proficient with Microsoft Office Suite or related software.

Bachelor's Degree in Life Sciences, Chemistry, Microbiology, Engineering, Pharmacy, or related discipline required. Advanced degree preferred.

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 in supporting commercial manufacturing operations required.

Experience supporting FDA and / or EU regulatory inspections.

Demonstrated knowledge of cGMP regulations and quality system requirements.

Experience with electronic Quality Management Systems (eQMS).

Prolonged periods of sitting or standing at a desk and working on a computer.

Must be able to lift up to 15 pounds at times.

Adheres to consistent and predictable in-person attendance

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:

Serán 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 our employees’ wellbeing, along with access to pet insurance.

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