Clinical Quality Assurance Specialist

POSITION TITLE: Clinical Quality Assurance Specialist

DEPARTMENT: Quality Assurance

Ora Values the Daily Practice of …

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

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At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.

The Role:

The Clinical Quality Assurance (CQA) Specialist will be instrumental in ensuring accuracy and efficiency throughout every aspect of Ora's projects. The CQA Specialist provides support to the Clinical Quality Assurance Management staff. Our CQA Specialists are responsible for conducting clinical processes in accordance with guidelines and regulations and work with quality management, external auditors, and clinical project teams to ensure ICH, GXP and local regulatory compliance obligations are met across the organization. In this role, you are expected, with oversight, to prepare, update/revise and maintain all Quality Management System Documents (Standard Operating Procedures (SOPs), Policies, Working Practices (WPs), Forms/Templates and manuals). You will be expected to conduct vendor qualification, internal system, eTMF and clinical site audits on behalf of Ora Clinical's Quality Management Department. This person will be assigned to Pivotal/Phase 3 Clinical Projects to be the point person of quality for the project team. This person will be responsible for performing review and approval of study start up documentation for clinical trials.

What You'll Do:

• Perform as a liaison under the direction of CQA Management staff, for client audits of Ora, including general qualification audits as well as project-specific audits. Maintains a system to track the progress status of audits step-by-step from scheduling through to acceptance of all responses and audit closures.
• Leads and conducts vendor, clinical site, internal systems, and eTMF Good Clinical Practice (GCP) audits
• Perform assigned vendor audits to ensure that Ora suppliers have suitable quality systems and meet required service expectations
• Responsible for tracking audit findings and following up with the vendor, clinical site, or internal staff to ensure all responses are accepted and closed
• Maintains adequate records of all quality and operational activities
• Ensures compliance with company SOP's, study protocols, and industry regulations, standards, and guidelines
• Under the direction of CQA Management team, serves as QMS subject matter expert (SME) for project teams
• Provides the project team with quality information, guidance, interpretation and training by attending key client and team meetings as the Clinical Quality Lead for selected projects
• Provides Inspection Readiness support to Ora's teams (back-room)
• Comply with Ora's integrity and business ethics requirements
• Adhere to all aspects of Ora's quality system.
• Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements.
• Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.
• Responsibilities may differ from the above based on the specific needs of the business.
• Travel Requirements domestically up to 50%

What We Look For:

• Experience needed for the Role:
  • Bachelor's degree in Life Sciences or other related, scientific field
  • 3 years' experience in quality-related field
  • Minimum of 2 years of related clinical operations experience in a pharmaceutical or Clinical Research Outsourcing (CRO) environment
  • Minimum of 1 year's experience in Good Clinical Practice (GCP)/Good Laboratory Practice (GLP)/Good Manufacturing Practices (GMP) related discipline/Quality Assurance role

• Additional Skills and Attributes:
  • Knowledge of clinical processes and procedures FDA regulations, ICH Guidelines, GCP, and relevant regulatory requirements
  • Knowledge of GLP and/or GMP guidelines
  • Must be able to work with autonomy and be highly self-motivated
  • Strong interpersonal skills
  • Excellent organization and time management skills
  • Excellent verbal and written communication skills

• Competencies and Personal Traits:
  • What We Do:
    • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
  • How We Do It:
    • IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
    • Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
  • Why We Do It:
    • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.

What We Offer:

• Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.
• Financial: Competitive salaries along with a 401K plan through Fidelity with company match.
• Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.
• Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure.
• Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases.
• Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family.
• Career Development Opportunities: Continued opportunities to grow and develop your career journey.
• Global Team: Opportunities to work with colleagues across the globe.
• Impact: A chance to research new ophthalmic therapies that will impact patients across the globe.

Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.

Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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