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Vice President of Quality and Regulatory Compliance

2 months ago

Brighton, Michigan, United States Bryllan LLC Full time
Job Overview

Are you seeking a fulfilling career in a dynamic and expanding organization? Do you thrive in collaborative environments aimed at achieving shared objectives? If you are passionate about enhancing the well-being of others, this role may align with your aspirations.


Bryllan LLC is on the lookout for dedicated, respectful, and courageous professionals who are eager to apply their expertise in a meaningful career. We invite you to leverage your knowledge and experience to proactively shape, lead, and implement the Quality Assurance and Regulatory Affairs initiatives within the pharmaceutical manufacturing sector. As a contract manufacturing organization (CMO) specializing in sterile injectable pharmaceuticals, Bryllan is committed to a management philosophy grounded in Quality, Integrity, and Service. If the prospect of contributing to the development of life-enhancing or life-saving products excites you, this position could be a perfect fit.


As a privately owned and rapidly expanding CMO, Bryllan has created a distinctive sterile filling and containment platform for the multi-product filling of a diverse array of drug products and containers. We provide a rewarding work environment while fostering a small company atmosphere focused on employee engagement. We are currently in search of a dynamic Vice President of Quality and Regulatory Affairs to become a vital part of our senior management team. This role entails the proactive development, leadership, and execution of the company's quality assurance and regulatory strategy, ensuring alignment with customer needs and capacity growth while balancing business objectives with regulatory compliance.

The Vice President of Quality will play a crucial role as an active member of the Senior Leadership team, ensuring that Quality and Regulatory objectives remain a central focus of the company’s strategic goals.


Key Responsibilities:


Quality Assurance & Compliance

  • Actively participate in the Leadership Team to formulate and establish the company's Quality and related strategies and objectives.
  • Ensure Bryllan achieves necessary regulatory approvals.
  • Provide guidance and direction to the Quality organization.
  • Mentor and oversee the development of Quality Assurance, Quality Systems, and Quality Control personnel.
  • Hold ultimate accountability for quality and compliance matters within the organization.
  • Make strategic decisions that significantly influence the company’s overall direction.
  • Direct and manage Quality Assurance activities with substantial organizational and product implications.
  • Align departmental goals with corporate objectives to ensure quality-related targets are met.
  • Oversee staffing within the Quality Assurance department, including management in a virtual setting.
  • Advise the Leadership Team on regulatory compliance matters.
  • Serve as the primary spokesperson regarding regulatory compliance with customers and regulatory bodies.
  • Collaborate with all Bryllan employees to integrate the quality management system across all operations.
  • Ensure vendor compliance with applicable quality regulations.

Regulatory Affairs

  • Lead the Regulatory Affairs team in developing and executing regulatory strategies to secure product approvals globally.
  • Provide training and guidance on FDA and other regulatory requirements to all personnel.
  • Oversee the preparation and submission of regulatory documents to the FDA and international agencies.
  • Establish and maintain relationships with key opinion leaders, medical directors, and regulatory officials.
  • Direct the development of systems and processes for ongoing review of product design and manufacturing changes.

Quality Control and Microbiology

  • Supervise the analytical and microbiology laboratory functions, including:
    • Release of raw materials and components
    • In-process testing
    • Finished product release testing
    • Environmental Monitoring
  • Provide leadership during significant deviation events that may affect compliance or present business risks.

Qualifications:

  1. Education & Experience:
    • BA/BS degree in life sciences, engineering, or business.
    • 15+ years of experience in pharmaceutical quality and regulatory affairs within sterile manufacturing, CMO, or technology-driven life sciences companies.
    • Extensive knowledge of cGMP and other regulatory compliance standards.
    • Experience in strategic planning and collaboration with executive and operational teams.
    • Proven leadership record in managing quality, regulatory, and analytical organizations with a focus on long-term strategic growth.
    • Familiarity with all phases of the product development lifecycle, including concept, design, implementation, verification, and validation for product commercialization.
    • Experience with regulatory filings for NDAs/ANDAs/MAs and other submissions.
  2. Required Skills & Abilities:
    • High personal and professional integrity with a strong work ethic and ability to work independently.
    • Excellent communication and presentation skills.
    • Capability to develop and manage a high-performance team focused on accountability.
    • Ability to lead and influence within cross-functional teams.
    • Assertive and results-oriented manager with a proactive attitude and urgency to achieve objectives.
  3. Success Metrics:
    • Development and implementation of Quality Assurance processes ensuring site and product approvals.
    • Execution of regulatory strategies enabling the company to meet product development and commercialization goals.
    • Collaboration with the Senior Operating team to ensure continuous annual growth and profitability.

Preferred Qualifications:

  • M.B.A. or other relevant advanced degree.

Physical Requirements:

  • Ability to sit, stand, and/or walk for at least 8 hours a day.
  • Willingness to travel domestically and internationally as required, likely no less than 15% of the time.