Vice President of Quality

Vice President of Quality – Flexible

NuvOx Pharma

Company:

NuvOx Pharma is a biotechnology company located in Tucson, Arizona developing a novel oxygen therapeutic to treat life-threatening diseases where hypoxia plays a role. The company is in the clinical stage for stroke and oncology. We are small, but passionate about bringing this impactful technology to patients.

Position:

The Vice President of Quality is a flexible position, where he/she is responsible for providing Quality leadership and oversight, with the support of a quality specialist employee, to ensure that NuvOx Pharma’s products are manufactured, tested, stored, and distributed according to FDA regulations and other areas of compliance as directed by the company. As such, we accommodate various of arrangements, whether you are a consultant, looking for extra engagements/employment, or semi/in retirement. We look to your leadership as you are passionate about biotech/life science industry, mentoring/building the function, and helping us as a humble start-up to reach the high dreams.

Primary duties may include, but are not limited to:

· Set strategic direction and provide oversight of the for the Quality Management System

· Ensure compliance with applicable internal and external regulations, standards, policies and procedures related to the quality and regulatory status and performance of company operations, processes and products, including GMP and GCP

· Lead the Document Control, Archiving and Training functions

· Implement quality planning, control and improvement practices in a risk-based manner across the company’s pipeline

· Provide guidance to personnel performing investigations, root cause analysis, CAPAs and deviations associated with oversight of clinical trial execution and commercial manufacturing

· Evaluate quality and compliance issues and determine corrective actions and need for escalation

· Support submission of INDs

· Participate in cross-functional teams (Regulatory, CMC, Clinical) supporting the overall strategy, design, and execution of the Company’s pipeline

Technical Knowledge and Expertise:

· Broad experiences in overall quality system establishment and management (Ideally, you have built quality system from ground up)

· Strong knowledge of cGMP regulations, practices, and trends pertaining to pharmaceutical product development, and 21 CFR Part 210/211.

· Able to ensure completeness, accuracy, and compliance of all documentation including but not limited to CAPA management, supplier management, manufacturing, and testing.

· Proficient in MS Word, Excel and PowerPoint.

Working Style:

· You will have to say “No” in tough situations and manage the risk. However, you are solution driven, always focus on what CAN be done, not just an auditor who focuses what CANNOT be done.

· We have very talented employees who are eager to learn and grow. We will look to you for mentoring and a development plan for them.

· You have proven skills in critical thinking and problem-solving, and organization. Must use good judgment and work well under pressure.

Education/Experience: A bachelor’s degree and/or the equivalent experience in Manufacturing, Quality Assurance, and Quality Control. Experience with implementation/improvement of quality systems and internal auditing. Minimum five years’ experience within FDA regulated industry is required.

Reports to: Chief Executive Officer

Employment Type: Flexible

Job Types: Full-time, Part-time

Pay: From $40.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

COVID-19 considerations:
We require all non-vaccinated employees to wear a mask indoors.

Education:

• Bachelor's (Preferred)

Work Location:

• One location

Work Remotely:

• Temporarily due to COVID-19

Work Location: One location