Who We Are…
Novasenta’s mission is to transform medicine by enabling innovative drug discovery at the interface of disease, immunity, and metabolism. Novasenta uses a next generation drug discovery approach combining unique experimental and computational tools to explore the human tumor microenvironment and discover novel therapeutically relevant targets and drugs. We are looking for candidates who have a passion for improving the lives of patients with cancer.
Summary of the Job
The Associate Director of Quality Assurance (GMP/GLP/GCP) at Novasenta is a pivotal leadership role responsible for maintaining and improving quality standards in pharmaceutical and biotechnology settings. Reporting directly to the VP, CMC and Regulatory Affairs, this position oversees the implementation of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) principles across all relevant functions within the organization.
Job Responsibilities:
- Develop and execute quality assurance strategies and policies tailored to the pharmaceutical and biotech environment, ensuring compliance with GMP, GLP, and GCP regulations.
- Manage the organization’s Quality Management System (QMS), overseeing the development, implementation, and maintenance of quality procedures, documentation, and records.
- Conduct thorough internal and external audits and assessments to evaluate adherence to regulatory requirements and company standards, identifying areas for improvement and implementing corrective actions as needed.
- Collaborate closely with cross-functional teams, including R&D, manufacturing, clinical operations, and regulatory affairs, to ensure that quality standards are integrated throughout the product lifecycle.
- Review and approve GMP/GLP/GCP documentation, including protocols, batch records, validation reports, and regulatory submissions, ensuring accuracy, completeness, and compliance with relevant guidelines.
- Lead investigations into quality issues, deviations, and non-conformances, implementing effective corrective and preventive actions to mitigate risks and prevent recurrence.
- Prepare the organization for regulatory inspections and audits, ensuring readiness and compliance.
- Provide training and guidance to staff on GMP/GLP/GCP requirements, quality systems, and best practices, fostering a culture of quality awareness and accountability.
- Stay current with changes in regulations, industry standards, and best practices related to GMP/GLP/GCP, and proactively implement updates to quality systems and processes.
- Drive continuous improvement initiatives to enhance quality processes, optimize efficiency, and elevate overall quality performance within the organization.
Job Requirements:
- Bachelor’s degree in a scientific or related field; advanced degree preferred.
- Minimum of 7 years of progressive experience in quality assurance roles within the pharmaceutical or biotechnology industry, with a focus on GMP/GLP/GCP.
- In-depth knowledge of GMP, GLP, and GCP regulations and guidelines, including FDA, EMA, and ICH requirements.
- Demonstrated leadership and managerial skills, with a track record of effectively leading teams and driving results in a highly regulated environment.
- Strong analytical and problem-solving abilities, with meticulous attention to detail and the ability to critically evaluate complex data and situations.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and influence stakeholders at all levels of the organization.
- Experience with regulatory inspections and audits is highly desirable.
- Professional certification in quality management (e.g., ASQ Certified Quality Auditor) is a plus.
What we Offer:
- Highly competitive pay and benefits package.
- Medical/Dental/Vision Insurance
- Annual bonus based on individual and company performance
- Stock Options
- Free parking for those routinely working in the office
- Unlimited PTO
- Retirement Plan with company match
- A dynamic, fast-paced startup culture combined with the stability of a well-established entity (UPMC Enterprises).
- Extensive opportunities for individual growth and professional development.
- Work with experienced leaders in computational sciences, drug discovery, immunotherapy, and cancer fields.