Job Purpose

As part of the Ocugen team, the Quality System Specialist will implement and manage the Ocugen Veeva and other GxP applications to meet regulatory requirements and business needs.

The ideal candidate should bring experience working in enterprise application environments in life sciences with the ability to manage multiple projects across different functions. The candidate should also be experienced as a technical lead for IT (Information Technology) projects.

Duties and Responsibilities

Accountable for implementation/delivery of Veeva applications to meet Ocugen business needs with a focus on regulated functions:

• Help define project scope and deliverables to support business goals in collaboration with senior management stakeholders.
• Participate in the development of solutions and manage project/change timelines.
• Liaise with computer system vendors, Quality, and the business to coordinate implementation activities.
• Work with the business to develop system and user requirements.
• Define and oversee documentation of configuration and design specifications.
• Participate in the authoring and execution of implementation plans/qualification tests.
• Participate in the authoring of computerized system validation documentation.
• Author Ocugen CSV (Computer System Validation) standards, procedures, and work instructions.

Management Of System Operations in Veeva

• Management of system access and permissions.
• Perform change management activities.
• Design solutions and manage configuration.
• Liaise with users to resolve issues.
• Create reports based on defined requirements.
• Maintain system documentation.
• Build systems reports and dashboards.
• Propose standardization and harmonized approach for configuration.
• Manage major and minor release including risk-based approach for validation and implementation.

Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization.

• Bachelor’s degree in computer science or technology with at least 5 years of IT or Direct Veeva Administration Experience.
• 5 years of experience working on validated applications in a pharmaceutical or regulated environment.
• Experience and knowledge of quality and regulatory business processes.
• Direct hands-on experience implementing GxP computerized systems and maintaining validated state.
• Strong process improvement skills and orientation.
• Must have proven business and technology skills in successfully providing a customer-oriented technology solutions environment.
• Proven strong communication skills in interacting with users and technical communities.
• Ability to communicate ideas in both technical and user-friendly language.
• Collaborative working approach.

Computer Skills:

• Certified Veeva System Administrator - Required.
• Veeva Vault Owner/System Administration Experience (Quality QMS (Quality Management System), Quality QualityDocs and Training, RIMS/Submissions, Clinical, Safety, Station Manager, Vault Mobile, etc.)
• Experience with Other Regulated Applications would be an asset
• Database and computer networking knowledge
• Experience working on SaaS (Software as a Service) systems

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethics; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts team success above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit, Shares expertise with others.

Adaptability Able to adapt to changes in the work environment. Manages competing demands. Change the approach or method to best fit the situation. Able to deal with frequent changes, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to build knowledge and skills continuously; Shares expertise with others.

Dependability - Follows instructions, responds to management direction, takes responsibility for own actions, keeps commitments, commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies the appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; Completes projects on time and budget.

Working Conditions

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

Physical Requirements

This is a largely 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.