Associate Director of Quality Assurance, Operations

Serán BioScience; Bend (OR); On-site; USD 150,000 - 190,000; Full time

Job summary

Serán BioScience is seeking an Associate Director of Quality Assurance to oversee day-to-day QA operations, clinical manufacturing oversight, and warehouse activities, including disposition of raw materials and drug products. The role requires a results-driven QA leader with broad regulatory and quality systems experience.

You will lead continuous improvement, manage investigations, CAPAs, and inspections, mentor staff, and collaborate across functions to maintain cGMP compliance and timely

Qualifications

• Bachelor’s degree in scientific discipline; advanced degree preferred.
• 10+ years GMP and Quality experience in pharmaceutical manufacturing with oversight of OSD.
• Experience with FDA and EU regulatory inspections.

Responsibilities

• Lead and mentor QA personnel; oversee daily operations and staff development.
• Review investigations, CAPAs, complaints, and Change Management.
• Ensure cGMP compliance for raw materials, drug products, packaging, and warehouse.
• Manage department operations scheduling and continuous improvement initiatives.
• Support internal and regulatory audits and inspections.
• Define quality objectives and build cross-functional teams.
• Review SOPs and batch records; ensure release and disposition.

Skills

GMP knowledge

Quality assurance

Regulatory inspections

Leadership

Project management

Cross-functional

Investigations

Training mentoring

Communication skills

Problem solving

Change management

Client relations

People management

Quality systems

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Serán is seeking a QA Associate Director, who oversees the day‑to‑day operations of the Quality Assurance department with oversight of clinical manufacturing and warehouse activities in addition to disposition of raw materials and drug products. Required attributes include a results‑driven and broad‑minded quality assurance professional with extensive experience in compliance and regulations, quality systems management, investigations, training and mentoring, client relations, performance management, and change management. Extensive experience with direct or quality oversight of manufacturing operations is required.

The successful candidate will have excellent problem‑solving skills and will identify critical quality objectives, develop cross‑functional, collaborative, and creative teams, and improve, adapt, and execute practical solutions in competitive and fast‑paced environments.

Supervisory Responsibilities

• Leads and mentors Quality Assurance personnel.
• Recruits, interviews,hiresand trains new staff.
• Oversees daily workflow of the department.

Responsibilities

• Leads and implements continuous improvement initiatives to reduce risk and improve efficiency for the company’s quality systems and department operations
• Management and scheduling of department operations
• Oversees and conducts review and approval of Investigations, CAPAs, Complaints, and Change Management
• Review and approval of SOPs, batch records, raw material records, and certificates of conformance/compliance
• Responsible for Quality oversight of activities involving raw material, drug product manufacturing, packaging, labeling, and warehouse activities
• Assures cGMP compliance systems and processes are in place to support raw material and drug product review, release, storage, and shipping
• Defines and maintains a strong people management, training, and engagement culture to ensure a high and constantly improving right first‑time rate
• Supports internal audits, client audits and regulatory inspections

Required Skills and Experience

• Expert knowledge of GMP guidelines and Quality expectations for preclinical and clinical phase manufacturing operations
• In-depth understanding and application of cGMP principles, concepts, practices, and standards
• Experience with regulatory inspections by the FDA and EU authorities
• Ability to influence diverse stakeholders and drive accountability and decision‑makingcrossfunctionally
• Demonstrated ability to partner with other functional groups to achieve business objectives
• Experience organizing and managing group 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
• Communicateseffectively andmaintainsproductive relationships with coworkers, clients, and other contacts outside of the company
• Excellent organizational skills and attention to detail
• Strong analytical and problem‑solving skills
• Strong supervisory and leadership skills

Education and Experience

• Minimum of a bachelor’s degree, preferably in a scientific discipline. An advanced degree is preferred
• 10+ years previous GMP and Quality experience in the Pharmaceutical industry with quality oversite of Oral Solid Dose manufacturing
• Experience with regulatory inspections by the FDA and EU authorities