Manager/Senior Manager Of Clinical Auditor

Job Details

Job Location: Main Corporate Office - Malvern, PA

Salary Range: Undisclosed

Description

Job Purpose

The Manager or Senior Manager of Clinical Auditor is responsible for proactively and comprehensively monitoring clinical vendor quality and compliance risk for vendors participating in GCP, GLP, GPvP, and CSV regulated environments across product modalities. This position is responsible for developing, maintaining, and disseminating vendor data and analytics, including but not limited to vendor key performance indicators, vendor quality metrics, and a vendor risk scorecard, to the head of quality and key business partners at the enterprise and program levels. The role also drives continuous improvement in Ocugen vendor quality processes and governance to ensure Ocugen remains adherent to regulatory expectations and supports QA operational quality oversight and management of complex vendor issues.

Direct responsibilities

• Responsible for vendor of early phase development to clinical quality function to ensure appropriate and timely vendor qualification and maintenance.

• Maintains and manages risk-based model for management and quality oversight of GCP, GLP, GPvP, and CSV vendors and suppliers, including conducting audits.

• Manage improvements and contribute to advancing the GCP, GLP, GPvP vendor program by identifying opportunities and implementing risk-appropriate enhancements to the vendor oversight infrastructure.

• Serve as SME and participate in inspection preparation and management activities for selected vendors as appropriate.

• Support functional area to resolve observations and quality issues arising across vendors, including but not limited to:

• Risk/impact assessment, specifically with respect to impact across vendors.

• CAPA development, execution, and effectiveness assessment.

• Maintain and evolve models and mechanisms for ensuring awareness and application of QMS requirements (e.g., qualification, agreements, vendor change notification process) across GxP vendors.

• Partner with the QA team and provide input to audits of GxP vendors.

• Provide quality consultation/direction to internal Clinical Development, Clinical Operations, R&D, IT, and CMC regarding vendor management inquiries.

• Lead and/or participate in process improvement projects to evolve quality systems/processes.

• Oversee developing and maintaining vendors standards, procedures, and work instructions related to GxP activities.

• Participate in strategic planning with a focus on meeting corporate quality goals.

• Promote a culture of quality across the company and reflect Ocugen's core values as a leader; train/mentor staff cross-departmentally on GxP VQM.

Qualifications

• M.S. (or equivalent degree) and 3-5 years of relevant work experience, or B.S. in a scientific or allied health field and 8+ years of relevant work experience or relevant comparable background.

• Supplier relationship building and supplier expectations management.

• At least five (5) years of experience with vendor/audit management in the GCP space.

• Experience participating in cross-functional teams.

• Experience using computerized systems especially Veeva, including Electronic Document Management (eDMS), Electronic Quality Management System (eQMS), Electronic Learning Management (eLMS), Electronic Trial Master File (eTMF), etc.

• Proficiency in using MS Office applications required (including MS Word, MS Excel, and PowerPoint).

Knowledge and skills:

• Demonstrated ability to work well in a matrixed, collaborative environment.

• Demonstrated working knowledge and experience applying US and international/global regulatory requirements, associated guidance, and standards applicable to drugs, biologics, vaccines, cell and gene therapy, development, manufacturing, and distribution.

• In-depth knowledge of and ability to interpret and apply FDA, EU, WHO, PMDA, and ICH regulations and guidelines.

• Strong working knowledge of risk and issue management, with a demonstrated ability to apply to third-party suppliers conducting GxP-governed activities.

• Strong oral and written communication and people skills to communicate difficult concepts and persuade others.

• Strategic "big picture" thinking while maintaining the ability to collaborate effectively and execute efficiently at a tactical level.

• Strong analytical thinking skills, with the ability to translate data into risk-informed insights that drive decision-making.

• Skilled in influencing and escalating within a matrixed organization to drive decisions.

• Demonstrated experience with key performance indicators and quality metrics for vendors.

• Experience advising, coaching, or mentoring junior staff.

Working Conditions

This position operates primarily in an office setting and may include 10% to 25% of travel.

Physical requirements

This is a sedentary role.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past,

current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.