Director, Quality Affairs

Diagnostic Green; Farmington Hills (MI); On-site; USD 120,000 - 150,000; Full time

Job summary

A leading biopharmaceutical company in Michigan is seeking a Director of Quality Affairs to ensure FDA regulatory compliance and oversee the Quality Management System. Responsibilities include managing GXP activities, conducting compliance audits, and developing quality standards. The ideal candidate will have over 10 years in the biotech industry, strong leadership skills, and a solid understanding of regulatory requirements. This role also involves collaborating with teams to support clinical development programs and ensure compliance at all levels.

Qualifications

• 10+ years in GMP, GLP and GCP within the biotech/pharma industry.
• Experience in ANDA and NDA FDA inspections.
• Strong understanding of ICH, GMP, GCP and relevant regulations.

Responsibilities

• Lead quality activities and compliance audits.
• Manage the Quality Management System.
• Develop standards and procedures for compliance.

Skills

GMP compliance

GLP compliance

GCP compliance

Project management

Regulatory knowledge

Communication skills

Interpersonal skills

Leadership

Education

BS/BA degree in life sciences

Advanced degree (preferred)

Tools

Microsoft Office Suite

Job description

The Director Quality Affairs is in charge of providing subject matter expertise on matters related to FDA regulatory compliance requirements, as well as leading the growth and responsibilities of the Quality Department. Responsible for maintaining the company’s Quality Management System’s (QMS). The Director represents the company in key stakeholder and strategy meetings on all quality matters related the company’s assets (development and manufacturing), including meetings with executive leadership, meetings with FDA and other regulators, and working with development and manufacturing partners. This role combines scientific, regulatory, and business knowledge to assure that products are developed within GXP compliance while meeting the company’s strategic goals.

Essential Duties and Responsibilities

Quality

• 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.

Operations

• As the company grows, build a strong quality team to meet the needs of the business.
• Develop and mentor quality staff/personnel.

Supervisory Responsibilities

• Yes, in the future

To perform the job successfully, an individual should demonstrate the following competencies:

• 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.

Education and/or Experience

• BS/BA degree or equivalent (background in life sciences preferred). Advanced degree preferred.
• 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