General Description

Biovire Inc. is privately owned, rapidly growing Contract Manufacturing Organization that has designed a unique sterile filling and containment platform for multi-product filling of 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 is obligated to be compliant in support of our customers. We are currently searching for a dynamic Vice President of Quality and Regulatory Affairs to join our senior management operating team. The Vice President of Quality and Regulatory will proactively develop, lead, and drive the execution of the Company's quality assurance and regulatory strategy from early stages through to commercial scale manufacturing in line with customer need and capacity expansion, balancing the business needs with regulatory compliance. Overall responsibility for leading the corporate product quality systems, including the setting of quality goals, managing, and improving all aspects of the quality system and product quality with an emphasis on customer products and expectations.

The Vice President of Quality will Serve as a key and active member of the Senior Leadership team to ensure that Quality and Regulatory objectives are a key focus of the company's goals.

DUTIES AND RESPONSIBILITIES

Essential Duties and Responsibilities:

Quality Assurance & Compliance

o Serves as an active member of the Leadership Team responsible for development and setting of company Quality and Quality-related strategy and goals

o Assures Biovire gains site regulatory approval

o Provides leadership and direction to the Quality organization

o Provides mentorship, oversight and development for the Quality Assurance, Quality Systems and Quality Control staff

o Holds final accountability for and decision-making on matters relating to quality and compliance for the company

o Make decisions focused on key quality- strategic and operational matters that have a significant, direction-setting impact on the company overall.

o Direct and control the activities and outcomes of Quality Assurance which has a significant organizational and product impact

o Sets and aligns goals and objectives for the Quality Assurance department with the overall corporate goals and objectives

o Ensures that the quality-related goals and objectives are accomplished

o Accountable for Quality Assurance departmental staffing and must be comfortable supervising and operating in a 24/5 operation

o Provides advice to the Leadership Team on regulatory compliance issues

o Serves as the principal spokesman with customers, regulatory agencies, etc., on matters of regulatory compliance

o Works with all Biovire employees to align and integrate the quality management system in all operational activity

o Accountable for vendor adherence to all applicable quality regulations

Regulatory Affairs

o Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide.

o Provide counsel, training and interpretation of FDA and other regulatory requirements to all company personnel.

o Oversee preparation and filing of all regulatory documents with the FDA and international regulatory agencies.

o Develop and maintain external relationships with key opinion leaders, medical directors, and regulatory officials.

o Direct the development of systems, practices, and processes to ensure effective ongoing review of product design and/or manufacturing changes and adverse events.

Quality Control and Microbiology

o Oversee the functions of the analytical and microbiology laboratory, including:

· Release of raw materials and components

· In-process testing

· Finished product release testing

· Environmental Monitoring

· Provide leadership and direction for significant deviation events that may impact compliance status or significant business risk.

Skills:

WORK EXPERIENCE AND EDUCATION REQUIREMENTS

1. Education & Experience:

• 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.

1. Required Knowledge, Skills & Abilities:

• High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
• Excellent communication and presentation skills.
• The ability to develop and manage a high-performing team focused on accountability while meeting and exceeding expectations.
• Ability to lead, influence, create and work within cross-functional team environments.
• Assertive, take-charge, proven manager with a strong results orientation, positive "can do" attitude and a sense of urgency to get things done.

1. Success Metrics:

• Development and execution of Quality Assurance processes which assure site and product approvals.
• Execution of regulatory strategies which enable the company to achieve set objectives including product development, commercialization, and continuity of supply.
• With the Senior Operating team, ensure continual annual growth with corresponding profit.

Preferred:

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

Physical Requirements:

1. Ability to sit, stand and/or walk for no less than 8 hours a day.

• The ability to travel domestically and internationally via plane, train and car as required, which is likely no more than 15%.