Establish, lead and develop the quality function in line with the company’s stage
Ensure global regulatory, industry, and corporate standards are met
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 compliance with GXP standards
Ensure the identification, evaluation, and management of risks associated with quality
Maintain and continuously improve the Quality Management System
Build relationships with stakeholders to ensure compliance with regulations
Work closely with teams to incorporate quality considerations throughout product development
Ensure timely resolution of quality issues and deviations
Lead the quality review process for batch records and testing documentation
Develop and implement risk-based quality strategies
Manage quality-related activities for manufacturing and clinical trials
Oversee vendor quality program adherence and prepare for regulatory inspections
Develop, implement, and maintain quality systems and training records
Lead quality investigations to address quality issues
Stay updated on industry developments and provide training on regulations
Ensure preparedness for regulatory inspections
Build, mentor, and provide leadership to the quality assurance 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

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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Quality Management Systems (QMS)GMPGCPICH guidelinesquality risk assessmentrisk mitigationGXPCSVquality investigationsregulatory inspections

Soft Skills

leadershipinterpersonal skillscommunication skillscollaborationflexibilityproactivityresourcefulnessefficiencyproject managementteam motivation