Quality Assurance Manager

Skye Bioscience takes pride in fostering a welcoming and inclusive community of passionate biotech enthusiasts who are united by their commitment to scientific excellence. Our workplace culture is built on fundamental values that guide everything we do: we champion supportive collaboration that enables breakthrough innovations, demonstrate purposeful and authentic passion in our pursuit of solutions, uphold unwavering integrity in all our actions, embrace personal and collective accountability, and maintain the highest quality standards in our research and development processes. These principles form the foundation of our approach to advancing therapeutic solutions and improving patient outcomes.

About Skye:

At Skye Bioscience, we are dedicated to pioneering innovative therapeutic solutions through the development of novel mechanisms and breakthrough drugs. Our mission is to expand and enhance treatment options available to the rapidly growing population of patients who face challenges with obesity and its associated metabolic conditions. Through rigorous research and development, we strive to create transformative solutions that can make a meaningful difference in patients' lives.

Skye Bioscience takes pride in fostering a welcoming and inclusive community of passionate biotech enthusiasts who are united by their commitment to scientific excellence. Our workplace culture is built on fundamental values that guide everything we do: we champion supportive collaboration that enables breakthrough innovations, demonstrate purposeful and authentic passion in our pursuit of solutions, uphold unwavering integrity in all our actions, embrace personal and collective accountability, and maintain the highest quality standards in our research and development processes. These principles form the foundation of our approach to advancing therapeutic solutions and improving patient outcomes.

About the Role:

We are looking for an experienced and knowledgeable Quality Assurance Manager to lead and support a range of quality-related activities. This includes ensuring GXP (GMP, GCP and GLP) compliance, managing a quality management system, overseeing manufacturing, testing, and distribution and making quality and compliance decisions for a diverse range of products.

Responsibilities:

• Ensure compliance for clinical manufacturing of phase I/II/III investigational biological product, and compliance with GMP and GCP regulations.
• Conduct and support third-party audits of current and proposed vendors to assess cGMP compliance.
• Manage and maintain the SOP system, including drafting, revising, tracking, and training on SOPs.
• Review and resolve deviations, lead investigations, Out-of-Specification (OOS) reports, and proposed Corrective and Preventative Actions (CAPAs) from manufacturers
• Lead risk assessments and analysis.
• Support regulatory audits and inspections, including those conducted by the FDA, for the organization and its manufacturing partners.
• Manage change control, document control and perform batch record reviews as required.
• Batch record review and lot disposition activities, to ensure release of lots within prescribed timelines and in compliance with applicable regulatory submissions and regulations
• Develops and implements procedures, programs and policies that support GMP operations
• Serve as team leader in quality investigations and ensure corrective and/or preventative action plans to resolve potential product quality issues are appropriately implemented
• Participate in the Quality Metric review process, assess data for adverse trends, develop solutions and oversee implementation
• Continuous reviews of all systems and procedures (SOPs) for efficiency and regulatory compliance improvements.
• Provide oversight to clinical operations, and support regulatory submissions.
  
  

Qualifications:

• Bachelor’s degree in a technical or scientific discipline (e.g., biology, chemistry, pharmacy, or related field).
• Minimum of 7 years of experience in the pharmaceutical industry, with a focus on Quality Assurance and Quality Systems.
• At least 2 years of experience in a management role within QA is preferred.
• Strong understanding of cGMP compliance and quality standards for biological and pharmaceutical products.
• Willingness to travel to contract manufacturing sites, with potential international travel for audits.
  
  

Actual base salary for this role will take into consideration factors such as relevant experience, skills and qualifications for the role. Skye currently offers health benefits for eligible employees.

You must be authorized to work in the United States (required)

As an equal opportunity employer Stronghold does not discriminate against any applicant or employee based on race, color, sex, sexual orientation, gender identity, marital status, religion, national origin, ancestry, age, disability, military or veteran status,

Compensation Range: $100K - $150K