Vice President of Quality Assurance

5 days ago

Brighton, Colorado, United States Bryllan LLC Full time
Job Title: Vice President of Quality and Regulatory Affairs

Bryllan LLC, a rapidly growing Contract Manufacturing Organization, is seeking a highly experienced and skilled Vice President of Quality and Regulatory Affairs to join our senior management operating team.

Job Summary:

The Vice President of Quality and Regulatory will be responsible for developing, leading, and driving the execution of the Company's assurance and regulatory strategy from early stages through to commercial scale manufacturing. This includes setting quality goals, managing and improving all aspects of the quality system and product quality, with an emphasis on customer products and expectations.

Key Responsibilities:
  • Serves as an active member of the Leadership Team responsible for development and setting of company Quality and Quality-related strategy and goals
  • Assures Bryllan gains site regulatory approval
  • Provides leadership and direction to the Quality organization
  • Provides mentorship, oversight and development for the Quality Assurance, Quality Systems and Quality Control staff
  • Holds final accountability for and decision-making on the matters relating to quality and compliance for the company
  • Makes decisions focused on key quality- strategic and operational matters that have significant, direction-setting impact on the overall company
  • Directs and controls the activities and outcomes of Quality Assurance which has a significant organizational and product impact
  • Sets and aligns goals and objectives for the Quality Assurance department with the overall corporate goals and objectives
  • Ensures that the quality-related goals and objectives are accomplished
  • Accountable for Quality Assurance departmental staffing and must be comfortable supervising and operating in a virtual organization
  • Provides advice to the Leadership Team on regulatory compliance issues
  • Serves as the principal spokesman with customers, regulatory agencies, etc., on matters of regulatory compliance
  • Works with all Bryllan employees to align and integrate the quality management system in all operational activity
  • Accountable for vendor adherence to all applicable quality regulations
  • Regulatory Affairs
  • Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide.
  • Provide counsel, training and interpretation of FDA and other regulatory requirements to all company personnel.
  • Oversee preparation and filing of all regulatory documents with the FDA and international regulatory agencies.
  • Develop and maintain external relationships with key opinion leaders, medical directors, and regulatory officials.
  • Direct the development of systems, practices, and processes to ensure effective ongoing review of product design and/or manufacturing changes and adverse events.
Requirements:
  • BA/BS undergraduate degree in life sciences, engineering, or business
  • 15+ years pharmaceutical quality, and regulatory and experience in a sterile manufacturing, CMO, or life sciences technology driven company.
  • Extensive experience in cGMP and other Regulatory compliance requirements.
  • Experience in strategic planning and collaboration with executive and key operational groups.
  • Progressive & proven record of leadership and managing quality/regulatory/analytical organization's establishing long term strategic growth initiatives.
  • Experience with all phases of the product development lifecycle, including concept, design, implementation, verification, and validation activities necessary for product commercialization.
  • Experienced in regulatory filings for NDAs/ANDAs/Mas and other regulatory filings.
Preferred Qualifications:
  • M.B.A. or other relevant advanced degree
Physical Requirements:
  • Ability to sit, stand and/or walk for no less than 8 hours a day.
  • Ability to travel domestically and internationally via plane, train and car as required which is likely no less than 15%.

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