Diagnostic Green · 1 week ago
Director Quality Assurance Regulatory Affairs
United States
Full-time
Remote
Director/Executive
10+ years expDiagnostic Green is seeking a Director of Quality Assurance Regulatory Affairs who will provide subject matter expertise on FDA regulatory compliance and lead the Quality Department. This role involves managing GXP quality activities, overseeing compliance audits, and developing strategies to ensure compliance with GMP, GLP, and GCP standards.
BiotechnologyManufacturingMedicalPharmaceutical
Hiring Manager
Trista Plawecki
Responsibilities
Manages GXP quality activities
Builds on the company’s Quality Management System; formulates the company’s GMP, GLP and GCP compliance strategies and provides advice and support for clinical development programs
Oversee GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, storage and distribution sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks
Oversee the QA reviews of GMP manufacturing and packaging batch records, product release and stability testing, validation reports, and essential clinical study documents
Assess all GMP compliance risks and develop and implement risk mitigation measures
Develops and implements standards, policies and procedures for GMP, GLP and GCP compliance
Partners with CMC, Clinical Development and Clinical Operations to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance
Participates in the evaluation and selection of contract manufacturing sites, analytical testing sites, storage and distribution, CROs and other service providers used to support the clinical development programs
As the company grows, build a strong quality team to meet the needs of the business
Manage quality vendors
Develop and mentor quality staff/personnel
Qualification
Required
Over 10 years of progressive advancement within GMP, GLP and GCP in the pharmaceutical/biotech industry
A thorough understanding of the drug development process along with knowledge of the developing regulations and guidelines
Ability to speak and interact with a diverse group of individuals on technical and business topics
Familiar with current regulatory legislation, industry trends, and health care business practices in the global arena
Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization
Strong presentation, written and verbal communication skills; a clear communicator who can influence stakeholders effectively, both internally and externally
Proven ability to lead and manage complex global projects to successful completion
Flexibility/agility to respond to Renew's evolving business needs
Strong ability to influence and gain credibility with both internal and external key stakeholders
Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex Quality issues, solicit information, listen well, persuade others, make important decisions and shape outcomes
Ability to build collaborative relationships both internally and externally
Ability to inspire, motivate and develop regulatory and quality teams
Ability to prioritize and handle multiple projects simultaneously
Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with scientists, managers, peers, and staff
BS/BA degree or equivalent
10 +yrs. of industry experience (biotech/pharma/CRO) with at least 8 years of QA experience
Experience in ANDA and NDA FDA inspections (sponsor, vendor and sites)
Strong understanding of ICH, GMP, GCP and relevant regulatory requirements
Strong operations and management skills with attention to detail
Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project
Preferred
Advanced degree preferred
Background in life sciences preferred
Company
Diagnostic Green
Diagnostic Green provides pharmaceutical products.
11-50 employees
Funding
Current Stage
Early StageRecent News
2025-09-15
Company data provided by crunchbase