---
title: 'Associate Director of Quality Assurance, Operations at Serán BioScience'
canonical: 'https://feeny.ai/job/associate-director-of-quality-assurance-operations-seran-bioscience-bend-3wttyg7eqb62'
type: 'job'
last_seen: '2026-09-11'
---

# Associate Director of Quality Assurance, Operations at Serán BioScience

- **Company:** Serán BioScience
- **Location:** Bend, OR
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-07-10
- **Last confirmed live:** 2026-09-11
- **Apply:** https://jobs.lever.co/seranbio/44d78798-af40-4757-9567-7c4016016ef0

## Job description

Serán is seeking a QA Associate Director,who oversees the day-to-day operations of the Quality Assurance department with oversite 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 oversite 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, hires and 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-making cross functionally
- 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
- Communicates effectively and maintains productive 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

Physical Requirements

- Prolonged periods of sitting at a desk and working on a computer
- Must be able to lift up to 15 pounds at time
- Adheres to predictable and consistent 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

## About Serán BioScience

## Company Overview
- **One-liner**: Serán BioScience is a science-driven drug development partner providing integrated formulation, particle engineering, and clinical manufacturing services to pharmaceutical and biotechnology companies.
- **Entity Type**: Private (Privately Held)
- **Headquarters**: Bend, Oregon, United States
- **Founded**: 2016
- **Founders**: Dr. Smithey (President, CEO, and Co-founder)

## Core Business
- **Primary Industry**: Biotechnology / Drug Development (Contract Development and Manufacturing Organization – CDMO)
- **Target Customers**: B2B – Pharmaceutical and biotechnology companies (from preclinical to commercial stage)
- **Mission**: To provide optimized drug development and manufacturing services for clients, from discovery to the clinic, using a science-first approach to accelerate medicines to patients.

## Products & Services
- **Preformulation Services**: Physicochemical characterization and early feasibility studies to guide formulation strategy.
- **Formulation Development**: Design of robust formulations for poorly soluble compounds using spray drying, hot melt extrusion, fluid bed processing, granulation, and solid dosage forms (tablets, capsules, multiparticulates).
- **Particle Engineering**: Custom-built spray dryers capable of producing nano-to-micro particles; expertise in spray-dried dispersions and engineered particles for inhalation.
- **Clinical Manufacturing**: cGMP manufacturing of clinical trial materials (suspensions, capsules, tablets) with on-site ICH stability storage.
- **Commercial Manufacturing**: A 100,000 sq ft commercial manufacturing campus under construction, including large-scale spray drying for late-stage clinical and commercial supply.
- **Quality Control Laboratory**: Full release, stability, and microbial testing capabilities.

## Market Standing
- **Valuation/Market Cap**: Not publicly available
- **Key Metric**: Total Funding – Not disclosed; Headcount of 146 employees (+0.6% YoY as of latest LinkedIn data)
- **Notable Investors/Partners**: Not publicly disclosed
- **Growth Signals**: Constructing a 100,000 sq ft commercial manufacturing facility; expanding team to over 200 members; adding new development facilities and quality control labs; LinkedIn follower growth of +29.1% year-over-year.

## Competitive Advantages
- **Science-First Approach**: Employs predictive design tools, novel chemistry, and advanced analytical methods from the earliest stages to de-risk development.
- **Particle Engineering Leadership**: Decades of experience with poorly soluble compounds; proprietary spray drying and particle engineering technologies (nano-structures to micro-particulates).
- **End-to-End Support**: Integrated services from preformulation through commercial manufacturing, reducing handoffs and timelines.
- **Right From the Start™ Methodology**: Parallel development of drug product intermediates and final dosage forms to accelerate programs.

## Strategic Focus
- **Commercial Scale-Up**: Investing in a dedicated commercial manufacturing campus to support clients’ late-stage and marketed products.
- **Technology Expansion**: Continuously expanding technical capabilities (spray drying, hot melt extrusion, fluid bed processing) and facility footprint.
- **Talent Acquisition**: Growing the team of scientists, engineers, and support staff to serve an increasing pipeline of complex drug molecules.

## Why Work Here
- **Culture**: Collaborative, respectful, and fun environment where every role contributes to delivering novel therapies. Emphasis on mentoring and continuous learning.
- **Work-Life Balance**: Central Oregon lifestyle with outdoor recreation access; standard business hours (with alternative shifts in manufacturing/QC/QA).
- **On-Site Requirement**: All employees are expected to work on the Bend campus; remote flexibility considered on a case-by-case basis.
- **Benefits**: Paid time off, employer retirement contributions (no match or vesting required after 90 days), fully funded medical/dental/vision for employee and household, basic life and long-term disability, Employee Assistance Program.
- **Ideal Applicant**: Scientific background with GLP/GMP knowledge; inquisitive problem-solver who follows SOPs and collaborates toward common goals.

## Sources
1. [seranbio.com](https://www.seranbio.com/about)
2. [linkedin.com](https://linkedin.com/company/seran-bioscience)
3. [seranbio.com](https://www.seranbio.com/careers)
4. [seranbio.com](https://www.seranbio.com/?portfolioCats=34%2C23%2C29%2C35%2C22%2C24%2C30%2C25%2C28%2C31)
5. [jobs.lever.co](https://jobs.lever.co/seranbio)

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