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- Durham, NC
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VP of Quality
ExecuNet • Durham, NC
Posted 2 months ago
Company, a biotechnology pioneer, discovers, develops and delivers innovative, award winning human biotherapies. We are currently developing multiple vascular tissue engineered therapies and expanding our business model. With a broad pipeline of potential new therapy applications, we continue to build our organization and scientific teams. We are looking for additional biomedical research and development colleagues to continue to build our expanding team.
Candidates will be expected to work both independently and collaboratively as part of the Company organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.
Company is seeking a VP of Quality who will work closely with the Chief Regulatory Officer, and the senior management team to provide quality and compliance strategy and leadership, vision, and general management skills to build a successful regenerative medicine company based on Company’s novel platform technology.
The VP of Quality will assume a leadership role in the company and will be responsible for helping to define, communicate and implement the company’s quality strategy and vision. The VP of Quality’s overarching mission will be to understand the regulatory and compliance landscape and requirements for Company’s first-in-class regenerative medicine product. This person will direct a team of QA professionals in the development of Quality Management systems, ensure that both internal (Manufacturing) and external (Supplier) processes are conducted with consistency and control, and will promulgate a culture of excellence and compliance throughout the organization. Maintaining outstanding relationships within the company, including with Regulatory, Manufacturing, Clinical Affairs and Process Development, will be key to the success of this role. Further, this person will foment a company-wide culture of excellence and creative problem-solving, fostering a “can-do” attitude that accepts challenges and devises solutions to drive success of this cutting-edge company. The successful candidate will foster methods for successful implementation of Company’s first-in-class regenerative medicine technology, and not be constrained to adopt “cookie-cutter” approaches to Quality Assurance.
The ideal candidate will be a seasoned pharmaceutical or biotechnology executive with an outstanding record of accomplishment, notably having led or played a key role in building a successful biotechnology or pharmaceutical company. Entrepreneurial approach and a strong record of execution are essential to ensure the position’s success.
This position reports to the Chief Regulatory Officer.
- Responsible for management of all corporate QA, Validation, QC Micro and QC Directors and Managers
- Establish and improve quality systems, initiatives, priorities and timelines
- Serve as an escalation point for corporate quality issues with regards to:
- Product complaints and investigations
- Product withdrawals, recalls
- Nonconformances and deviations
- Document change control
- Finished product sampling and inspection
- Equipment and product line clearances
- Internal and external audits
- Employee training
- Review and approve critical patient complaints and product investigations, helping to assess risk, identify root cause, CPA plans, and implementing solutions with business partners
- Work with quality subject matter experts to generate ideas for projects and process improvements
- Track and trend quality metrics and KPIs
- Discusses issues and concerns directly with operations management and senior leadership
- Collaborates with operational functions to troubleshoot manufacturing and production defects, CAPA, and customer complaints. Provides advice with process improvements to eliminate errors and reduce risk
- Discuss quality-related issues with regulators, as needed
- Monitors compliance to established Good Manufacturing Practice (GMP) guidance
- Conducts all duties in compliance with safety rules, applicable SOPs, and other applicable guidelines
- Formulates and recommends quality assurance (QA), quality control (QC) and validation policies and programs
- Develops departmental budget for quality assurance, validation and quality control, including defining materials, equipment and personnel needs
- Possess a positive attitude and optimistic outlook
- Motivated and organized critical thinker with solid interpersonal and business communication skills
- Demonstrated ability to work effectively with a team to set goals, develop sound project plans, monitor progress, and report results
- Routinely communicate and present findings and information to other team members; transparency and knowledge sharing is expected and practiced
- Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
- Detail-oriented, self-motivated and scientifically driven
- Strong analytical and problem-solving skills
- Demonstrated ability to work in a cross functional team
- Strong written and oral communication skills
- Innovative planner and builder rather than a “steady state” manager, who is passionate about Company’s technology and huge potential
- Propensity for establishing positive and success-oriented culture
- Quality leadership skills to assist in driving the broad utility of the platform technology
- Proven ability to rapidly become conversant with the company’s product and technology, along with the ability to communicate effectively and cogently to technical and non-technical regulators, inspectors, analysts and investors
- Strong communication and influence skills with the ability and personal style to inspire confidence and work successfully with varied audiences including industry partners, and the management team
- A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
- 15-20 years of full-time work experience is mandatory
- Recent experience in the biotechnology, medical, or medical device industries is strongly preferred
- Preference will be given to candidates with excellent experience interacting with regulators and inspectors at the Food and Drug Administration, as well as international regulatory bodies