Compliance Director

Job Description

The PDMB Regulated Bioanalytics Department is seeking a Director to lead the Compliance team within the Late Development (AdVAnce) Vaccines bioanalytical group located at our company's new state-of-the-art AdVAnce GxP research facility in West Point, PA.  At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data.  A combination of molecular (e.g., PCR), serology (e.g., ligand binding titer immunoassays), and cell-based assays (e.g., neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. The compliance team will ensure all operations, documentation, procedures, and filings meet all regulations and will focus on both the setup of these processes along with ongoing improvements.  As the AdVAnce facility will not be fully constructed and ready for occupancy until 2026, initial roles will complete training and perform work primarily at our company's Springhouse Innovation Park facility in Lower Gwynedd Township, PA. 

The successful Compliance Director candidate will lead a team that focuses on the development, oversight, and improvement of labs processes, procedures, and data systems to ensure high-quality bioanalytical testing.   Responsibilities will include technical writing (e.g. regulatory responses, SOPs, etc.), management of QA and regulatory inspections, review of data and lab processes, driving the evolution of systems and processes to ensure ongoing quality improvements, creating tracking mechanisms and monitoring lab key performance indicators (KPIs), and directly managing some lab operations (e.g. reagent prep, system validation, safety, etc.).  As a member of the Late Development Vaccines bioanalytical leadership team, the candidate will partner with other leaders in the setup of the new facility and labs, recruitment of top talent, and establishing an innovative and inspiring culture.   

Education Minimum Requirement 

• B.A./B.S. in Biology, Immunology, Biochemistry,  or a related scientific discipline with at least 15 years, M.S. with at least 10 years, or Ph.D. with at least 8 years of related experience 

Responsibilities 

• Provides leadership, mentorship, and coaching to managers to compliance team staff 

• Leverages deep compliance, quality, and/or regulatory expertise to implement and improve lab processes, systems, and procedures. 

• Leads technical writing of SOPs, bioanalytical procedures, deviations, investigations, trending reports, validation reports, filing documents and regulatory responses.   

• Conducts review of all laboratory data to drive high quality documentation, data integrity, staff adherence to procedures 

• Leverages IT tools to develop and utilize effective monitoring tools to track lab KPIs 

• Manages select lab operation functions to support reagent preparation, computer system validations, documentation template creation, and other operational aspects of the lab not managed by the assay or robotics teams.   

• Applies business and management expertise to set and achieve financial and operational objectives for the Compliance team 

• Influences others internally and externally, including senior leaders, internal customers, and external partners 

• Develops relationships with key stakeholders, including robotics, IT, quality, and other partnering organizations to drive improved, quality operations 

• Contributes to the development of departmental strategy and represents department on leadership and development teams 

• Develops priorities and objectives for the Compliance and Late Development team to align with division scorecard 

• Represents the Late Development Vaccines team during internal and external audits 

• Promotes our company’s scientific excellence and regulatory influence through leadership in the scientific community 

Required Experience & Skills 

• Experience working within a GLP, GMP, or other GxP laboratory 

• Experience in Agency inspections/audits   

• Experience with regulatory submissions 

• Experience using various IT tools for laboratory testing/documentation (ELNs, LIMS, etc.), review, audit, and/or monitoring of quality metrics 

• Demonstrated history of developing improved laboratory or quality processes 

• Ability to lead, mentor, and inspire staff at various levels; encourages curiosity in others and challenges the status quo to foster innovation 

• Demonstrated ability