Manager, Quality Assurance - Analytical and Client Services

The Manager, Quality Assurance - Analytical and Client Services is responsible for leading Quality Assurance activities that support analytical testing, laboratory operations, client programs, and quality system compliance. This position plays a key role in fostering a culture of quality, compliance, and continuous improvement while ensuring adherence to current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality standards.

The Manager partners closely with Analytical Services, Quality Control, and Client Services teams to ensure quality oversight of analytical activities, documentation, investigations, validations, and client-facing projects. The role is responsible for maintaining effective quality systems, mitigating compliance risks, supporting inspections and audits, and driving operational excellence across quality processes.

Supervisor Responsibilities

- Recruits, interviews, hires, and trains Quality Assurance personnel.

- Oversees the daily activities and workload distribution of assigned team members.

- Provides coaching, mentorship, and professional development opportunities.

- Conducts performance evaluations and establishes development plans.

- Promotes employee engagement, accountability, and a culture of continuous improvement.

Duties & Responsibilities

- Provides Quality Assurance oversight for Analytical Services operations, Quality Control, and client-sponsored projects.

- Serves as the primary QA liaison for assigned client programs and analytical activities.

- Reviews and approves quality documents including SOPs, protocols, reports, specifications, laboratory investigations, deviations, change controls, risk assessments, and method qualification/validation documentation.

- Supports implementation, maintenance, and continuous improvement of the Quality Management System (QMS).

- Ensures analytical and laboratory activities are conducted in compliance with cGMP requirements, internal procedures, client expectations, and applicable regulatory requirements.

- Leads and supports investigations associated with deviations, out-of-specification (OOS) results, out-of-trend (OOT) events, and laboratory nonconformances.

- Supports internal audits, client audits, and regulatory inspections.

- Assists in the development, execution, and monitoring of corrective and preventive actions (CAPAs).

- Reviews and approves laboratory method validation and qualification documentation.

- Supports management review activities through preparation and analysis of quality metrics and performance indicators.

- Identifies and mitigates quality and compliance risks through application of risk management principles.

- Collaborates cross-functionally to drive process improvements and operational efficiencies.

- Provides quality guidance and training to various functional groups throughout the organization.

- Monitors compliance trends and escalates significant quality issues to senior management when appropriate.

- Assists with preparation and maintenance of regulatory inspection readiness programs.

- Contributes to departmental objectives, strategic initiatives, and continuous improvement projects.

Required Knowledge & Skills

- Strong knowledge of cGMP regulations and quality systems applicable to laboratory testing for oral solid dose pharmaceuticals.

- Working knowledge of analytical testing methodologies and laboratory quality systems.

- Understanding of FDA, ICH, EU GMP, and other applicable regulatory requirements.

- Experience supporting GMP analytical laboratories and quality oversight activities.

- Ability to effectively manage multiple priorities and projects simultaneously.

- Strong problem-solving, root cause analysis, and risk assessment skills.

- Excellent verbal, written, and interpersonal communication skills.

- Ability to influence cross-functional teams and drive compliance-focused decision making.

- Strong organizational skills and attention to detail.

- Demonstrated ability to develop employees and lead teams effectively.

- Ability to work independently while exercising sound judgment.

- Proficiency in Microsoft Office Suite and electronic quality management systems (eQMS).

- Ability to communicate effectively with clients, auditors, and regulatory representatives.

Education & Experience

- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or another related scientific discipline required.

- Minimum of 10 years of GMP Quality Assurance experience within the pharmaceutical, biotechnology, or contract development and manufacturing (CDMO) industry.

- Minimum of 3 years of direct supervisory or management experience preferred.

- Experience supporting analytical laboratories, method validation programs, and quality systems required.

- Experience participating in FDA, client, and regulatory inspections preferred.

Physical Requirements

- Prolonged periods of sitting and working on a computer.

- Ability to occasionally walk production and laboratory environments.

- Ability to review documentation and perform detailed quality assessments.

- Must be able to comply with all applicable gowning and safety requirements when entering GMP-controlled areas.

- Must be able to meet in-office work requirements

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