Vice President of Quality

The Vice President of Quality will establish, lead and develop the quality function, in line with the company’s stage, while ensuring global regulatory, industry, and corporate standards are met. Reporting to the Senior Vice President of Regulatory Affairs this position will ensure the organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPV). This is a hands-on, strategic, and leadership role, ideal for a seasoned Quality executive passionate about small-molecule therapeutics in a dynamic biotech environment.

Key Responsibilities:

• Oversee GXP and Data Integrity activities across various entities, investigator sites, clinical and nonclinical studies, PV vendors, and CROs

• Maintain efficient systems and processes that ensure Contineum and its vendor network comply with GXP standards

• Ensure the appropriate identification, evaluation, and management of risks associated with quality

• Maintain and continuously improve the Quality Management System, providing guidance and strategic direction for GxP quality standards and their deployment.

• Build strong relationships with stakeholders, representing the company's interests and ensuring compliance with all relevant regulations

• Work closely with cross-functional teams to ensure that quality considerations are incorporated throughout the product development lifecycle

• Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and external teams to implement corrective and preventive actions

• Lead the quality review process, ensuring the effective review and approval of batch records, release testing, and other quality-related documentation

• Create and implement risk-based quality strategies that identify and address potential quality risks

• Manage quality-related activities related to manufacturing, clinical trials, and nonclinical studies, including conducting audits of vendors and sites, providing support during health authority inspections, and offering guidance on quality issues

• Ensuring vendors adhere to relevant quality programs, regulations, and guidelines, and preparing them for regulatory inspections

• Overseeing the development, implementation, and upkeep of quality systems and procedures, training records, batch records, quality metrics, standard operating procedures (SOPs) pertaining to GXP and PV activities

• Lead quality investigations and approve plans to address quality issues that impact products, as well as supervising corrective and preventive actions (CAPAs) for deviations and investigations

• Stay updated on industry developments, regulations, guidance, and best practices, and providing training and mentoring on global GXP/PV regulations and guidance

• Ensuring preparedness for pre-approval and routine regulatory inspections conducted by global Regulatory Health Authorities

• Build, mentor and provide leadership and direction to the quality assurance team, ensuring that all quality activities are carried out efficiently and effectively as the need develops for a team

Requirements:
• BS/BA in biology or related Life Sciences discipline, or equivalent experience

• Minimum of 15 years of experience with increasing responsibilities, including leadership of a Quality function with a focus on biotech or pharmaceutical product development

• Strong working knowledge of global regulatory requirements, including GMP, GCP, and ICH guidelines

• Expertise in Quality Management Systems (QMS)

• Extensive knowledge of quality risk assessment and management methodologies, with a successful track record in their application and risk mitigation

• Proven experience in establishing and managing a quality organization and GXP and CSV experienced team members

• Track record of success in a biotech start-up or fast-paced, innovative, dynamic environment, with the ability to remain flexible, proactive, resourceful, and efficient

• Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment

• Strong management, interpersonal, and communication skills, with a history of effectively collaborating with senior scientific, medical, and operations staff

• Demonstrated ability to lead and motivate cross-functional teams

• Willingness and desire to “roll up your sleeves” and perform activities and responsibilities to support the team

• Ability to travel 15%

Benefits:
We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates is $300,000- $350,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Contineum offers competitive compensation and benefits, including:

• 90% employer-covered benefits

• Flexible PTO

• A very generous holiday schedule that includes a week off in August and time off around the winter holidays

• A well-stocked kitchen with snacks and beverages

• Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match.

• The comprehensive wellness program includes medical, dental, vision, and LTD coverage.