Bryllan LLC
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Vice President of Quality
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Bryllan LLC
The information below covers the role requirements, expected candidate experience, and accompanying qualifications. 3 days ago Be among the first 25 applicants Join to apply for the
Vice President of Quality
role at
Bryllan LLC General Description Biovire Inc. is a privately owned, rapidly growing Contract Manufacturing Organization that has designed a unique sterile filling and containment platform for multi-product filling of a wide range of drug products and containers. We offer a rewarding work environment while maintaining a small company, employee-focused atmosphere. Biovire is committed to Quality and compliance in support of our customers. We are currently seeking a dynamic Vice President of Quality and Regulatory Affairs to join our senior management team. The Vice President will develop, lead, and execute the company's quality assurance and regulatory strategy from early stages through to commercial manufacturing, aligning with customer needs and capacity expansion, and ensuring regulatory compliance. The Vice President of Quality will serve as a key member of the Senior Leadership team, focusing on quality and regulatory objectives to support the company's goals. Duties and ResponsibilitiesQuality Assurance & Compliance
Develop and implement company quality strategies and goals. Ensure site regulatory approval and compliance. Lead and mentor the Quality Assurance, Quality Systems, and Quality Control teams. Make final decisions on quality and compliance issues. Manage quality assurance activities and staffing, including supervising a 24/5 operation. Serve as the main contact for regulatory agencies and customers regarding compliance. Regulatory Affairs
Lead regulatory strategy development and implementation for worldwide product approvals. Oversee preparation and submission of regulatory documents. Maintain relationships with regulatory authorities and key opinion leaders. Quality Control and Microbiology
Oversee analytical and microbiology laboratories. Manage release testing, environmental monitoring, and deviation events. Skills and Experience
BA/BS in life sciences, engineering, or business. 15+ years in pharmaceutical quality and regulatory roles, with experience in sterile manufacturing or CMO environments. Extensive knowledge of cGMP and regulatory requirements. Proven leadership and strategic planning skills. Experience with product development lifecycle and regulatory filings. Preferred Qualifications
MBA or advanced degree. Physical Requirements
Ability to sit, stand, or walk for at least 8 hours daily. Ability to travel domestically and internationally up to 15% of the time. Employment at Bryllan (Biovire) is contingent upon a successful background check. Additional Details
Seniority level: Executive Employment type: Full-time Job function: Quality Assurance Industry: Pharmaceutical Manufacturing
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Vice President of Quality
role at
Bryllan LLC
The information below covers the role requirements, expected candidate experience, and accompanying qualifications. 3 days ago Be among the first 25 applicants Join to apply for the
Vice President of Quality
role at
Bryllan LLC General Description Biovire Inc. is a privately owned, rapidly growing Contract Manufacturing Organization that has designed a unique sterile filling and containment platform for multi-product filling of a wide range of drug products and containers. We offer a rewarding work environment while maintaining a small company, employee-focused atmosphere. Biovire is committed to Quality and compliance in support of our customers. We are currently seeking a dynamic Vice President of Quality and Regulatory Affairs to join our senior management team. The Vice President will develop, lead, and execute the company's quality assurance and regulatory strategy from early stages through to commercial manufacturing, aligning with customer needs and capacity expansion, and ensuring regulatory compliance. The Vice President of Quality will serve as a key member of the Senior Leadership team, focusing on quality and regulatory objectives to support the company's goals. Duties and ResponsibilitiesQuality Assurance & Compliance
Develop and implement company quality strategies and goals. Ensure site regulatory approval and compliance. Lead and mentor the Quality Assurance, Quality Systems, and Quality Control teams. Make final decisions on quality and compliance issues. Manage quality assurance activities and staffing, including supervising a 24/5 operation. Serve as the main contact for regulatory agencies and customers regarding compliance. Regulatory Affairs
Lead regulatory strategy development and implementation for worldwide product approvals. Oversee preparation and submission of regulatory documents. Maintain relationships with regulatory authorities and key opinion leaders. Quality Control and Microbiology
Oversee analytical and microbiology laboratories. Manage release testing, environmental monitoring, and deviation events. Skills and Experience
BA/BS in life sciences, engineering, or business. 15+ years in pharmaceutical quality and regulatory roles, with experience in sterile manufacturing or CMO environments. Extensive knowledge of cGMP and regulatory requirements. Proven leadership and strategic planning skills. Experience with product development lifecycle and regulatory filings. Preferred Qualifications
MBA or advanced degree. Physical Requirements
Ability to sit, stand, or walk for at least 8 hours daily. Ability to travel domestically and internationally up to 15% of the time. Employment at Bryllan (Biovire) is contingent upon a successful background check. Additional Details
Seniority level: Executive Employment type: Full-time Job function: Quality Assurance Industry: Pharmaceutical Manufacturing
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