Director of Quality Assurance at Serán BioScience

Bend, Oregon, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

General knowledge of aseptic manufacturing processes
Expert knowledge of GMP guidelines and Quality expectations for preclinical and clinical phase programs
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
Broad knowledge of FDA and international regulations related to GMPs and Pharmaceuticals
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 organizational skills and attention to detail
Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts

Responsibilities

Identifies and eliminates risk to continuously improve customer satisfaction and product reliability
Leads and steers Quality Assurance (QA) Department, including hires and mentors QA personnel, provides constructive and timely performance evaluations, and handles discipline of employees in accordance with company policy
Leads implementation and continuous improvement of the company’s quality systems and facility validation
Creates product quality documentation system by writing and updating quality assurance procedures
Leads Quality System improvements, Investigations, CAPAs, Change Management, Document Control, Validation, and Auditing
Responsible for oversight of site activities, assuring that products are manufactured in compliance with cGMP, FDA, and EU guidelines
Documents authorship, reviews, and approves of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications
Supports internal audits, client audits and regulatory inspections
Provides support and oversight of Quality Management Review meetings
Oversight of a broad range of documentation including, but not limited to User Requirements Specifications (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Change Controls, and Risk Assessments
Maintains product quality by enforcing quality assurance policies and procedures and government requirements
Collaborates with other members of management to develop new product and engineering designs and manufacturing and training methods
Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends
Defines and maintains a strong people management, training, and engagement culture to ensure a high and constantly improving right first-time rate in manufacturing and QC
Manages the QA budget to ensure that resources are allocated appropriately and that all projects are completed on time and within budget
Responsibilities may increase in scope to align with company initiatives
Other related duties as assigned

Skills

GMP

cGMP

FDA

EU Guidelines

Quality Systems

CAPA

Change Management

Document Control

Validation

Auditing

SOPs

Batch Records

Investigations

Risk Management

Serán BioScience

Contract development and manufacturing for pharmaceuticals

About Serán BioScience

Serán BioScience specializes in providing drug development and manufacturing services as a Contract Development and Manufacturing Organization (CDMO). They offer a variety of services, including preformulation, formulation development, dosage form development, spray drying, and particle engineering. Their operations adhere to current Good Manufacturing Practice (cGMP) standards, ensuring high quality and safety in their products through rigorous analytical quality control. Serán BioScience serves a wide range of clients, from small biotech startups to large pharmaceutical companies, and is distinguished by its flexibility in tailoring services to meet specific client needs. The company's goal is to enhance the efficiency and effectiveness of drug development processes for their clients.

Bend, OregonHeadquarters

2016Year Founded

$194.5MTotal Funding

GROWTH_EQUITY_VCCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Paid Vacation

401(k) Retirement Plan

Health Insurance

Life Insurance

Disability Insurance

Mental Health Support

Pet Insurance

Risks

Emerging CDMOs in Asia offer lower-cost services, impacting Serán's market share.

Potential delays in new facility construction could affect expansion plans.

Global talent shortage may hinder recruitment for Serán's expansion.

Differentiation

Serán specializes in advanced drug formulation techniques, including spray drying and particle engineering.

The company offers cGMP manufacturing and analytical quality control services.

Serán's flexibility allows tailored services to meet specific client needs.

Upsides

Serán announced a $200 million strategic growth transaction for expansion.

The company plans to build a new commercial-scale manufacturing facility.

Increased demand for personalized medicine aligns with Serán's formulation expertise.

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