Manager, Validation

POSITION TITLE: Manager, Validation

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 forty years, our expert teams have helped earn more than fifty new product approvals. Today, our team continues to expand across the globe, with over 350 employees across the US, Europe, Australia, and Asia.

The Role:

The Manager, Validation at Ora is responsible for leading and directing all operational and strategic aspects of process validation in relation to GxP computer systems and software development lifecycle (implementation, validation, and decommissioning) as well as maintaining the validated state as they go through updates. This individual will also be asked to drive chamber validations for ensure controlled conditions. This individual will ensure that all company personnel are trained and understand their responsibilities with respect to process validation, this includes helping ensure all employees adhere to all standard operating procedures, as applicable to their individual roles and associated validation projects. In addition, they will be responsible for establishing quality goals and objectives and for establishing appropriate performance metrics to monitor trends requiring analysis and corrective action.

In summary, this individual will oversee overall corporate quality to ensure compliance with relevant guidelines, regulations, and standards; helping position Ora as the highest quality provider of CRO services and ensuring systems are validated and remain in validated state for supporting our internal and customer needs.

This role will report to Senior Director, Quality Assurance.

What You'll Do:

• Lead all validation efforts in line with QA principles and risk-based approach for both hardware and software in relation to GxP computer systems.
• Assess validation needs and present strategy for internal validations, or justification to utilize external validation partners.
• Facilitate verification and validation activities such as User Acceptance Testing (UAT), test execution, documentation review, and approval.
• Responsible for the conduct of internal audits for proper adherence to established procedures regarding system implementation and validation.
• Oversee and conduct external audits for proper adherence to established procedures and regulatory requirements. Ensure supplier qualification and risk assessments and validation strategy in place for all required systems. Review and approve key documents.
• Manage formal test execution of IQ, OQ and PQ, through active participation with business owner, to ensure testing is performed appropriately and results are compiled in a timely manner.
• Manage a list of systems and associated hardware and their current validation status.
• Work collaboratively with Ora teams on key corporate initiatives and assist with validation compliance.
• Lead validation incident management and timely adherence to our quality procedures including root cause, corrective and preventative actions, and effective checks. Ensures collaboration and expectations with all functional departments.
• Develop and deliver company-wide effective system validation in accordance with Ora's SOPs and industry expectations.
• Support business development and strategic planning activities, as required.
• Preparation and maintenance of all validation related documentation to include but not limited to standard operating procedures (SOPs) in support of Quality's vision.
• Serve as validation subject matter expert (SME) in meetings, and act as a quality assurance liaison with internal and external cross-functional teams, clients, and suppliers, as required.
• Help lead Ora's continuous improvement initiatives with respect to validation and prepare, revise, and control the company's SOP's.
• Adherence to all essential systems and processes that are required at Ora to maintain compliance to business and regulatory requirements.
• Clear and sustained demonstration of the Ora Clinical's Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.
• Responsibilities may differ slightly from the above based on the specific needs of the business.

What We Look For:

Experience needed for the Role:

• Bachelor's Degree in IT (MBA or other related advanced degree is preferred).
• 5+ years of experience in a related quality assurance validation position working with GxP computer systems.
• Experience with IQ, OQ, and PQ activities.

Additional Skills and Attributes:

• Identify and escalate potential risk area/shortfalls and make sure that the process remains in a validated state.
• Ability to quickly process complex information and make critical decisions with limited information.
• Experience reviewing/auditing GMP documentation.
• Familiarity with SAS validation, Veeva suite preferred.

Competencies and Personal Traits:

• Attention to Detail: Ability to analyze data to drive successful solutions to complex problems.
• Emotionally Intelligent Leadership: Ability to lead with a positive mindset and empathy.
• Intellectual Curiosity: Willingness and desire to learn new things and dig deeper than the surface.
• Innovative Mindset: Forward thinking, creative and open to testing, making mistakes and trying again.
• Organization and Goal Setting: Ability to set goals, develop structure and maintain a focused approach to critical path work.
• Resolve Conflicts: Practice radical candor in your communication and participate in active listening to help the other person feel heard and understood.
• 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.

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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