POSITION TITLE: Associate Director of Quality Systems

DEPARTMENT: Clinical 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 Associate Director of Quality Systems will lead the day-to-day operations of the Quality Management System (QMS) at Ora. This role will oversee document control, change management, corrective and preventative actions (CAPA), deviations, quality events and quality metrics reporting, as well as serve as the business owner/administrator of the electronic QMS (ZenQMS). The Associate Director will report to the Senior Director of Quality Assurance and will function as a People Leader for a team of direct reports.

What You'll Do:

• Provide strategic direction and oversight for Quality systems, tools and resources to drive compliance and mitigate risk for Ora's clinical operations activities.
• Define and manage effective QMS processes to meet applicable quality, clinical, and regulatory requirements.
• Lead the Quality Systems staff and oversee QMS activities.
• Collaborate with all levels of clinical operations to evaluate quality concerns, compel business accountability, identify nonconformities, recognize trends, and provide recommendations.
• Provide expert guidance to clinical operations leaders regarding creation of governance (Policies, SOPs, Work Instructions), management of periodic reviews and evaluation of employee impact.
• Serve as primary point of contact for all quality issues (CAPA, deviation, quality event, serious breach).
• Lead and/or direct CAPA investigations to evaluate incidents, determine actual root cause, assess risks, resolve quality issues and define action plans for proactive measures.
• Escalate deviations or quality events to appropriate leadership and prioritize timely reconciliation.
• Develop routine reports and scorecards for QMS metrics analysis.
• Collaborate with the Senior Director of Quality Assurance to redesign and implement a change management process.
• Partner with Information Services as required to perform systems qualifications, validations, and updates as needed.
• Collaborate with Learning & Development to design and deliver 21 CFR Part 11 compliant training for all users of Quality systems.
• Responsibilities may differ slightly from the above based on specific needs of the business.
• Clear and sustained demonstration of the Ora's Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.

What We Look For:

Experience Needed for the Role:

• Bachelor's Degree (minimum)
• 8 years of experience in quality or clinical operations roles within the pharmaceutical industry
• 5 years of experience managing employees
• 1 years of experience as an administrator of electronic document management systems and/or any other module within a Quality Management System

Additional Skills and Attributes:

• Experience developing and/or managing GxP quality systems including document control, change control, CAPA, and/or deviations.
• Strategic, influential leader with ability to drive quality initiatives, operational excellence, and continuous improvement across multiple functions.
• Advanced knowledge and experience in one or more of the following: Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Quality Control, Quality Assurance, Quality Compliance and/or Quality Audits.
• Advanced knowledge and experience authoring Policies, Standard Operating Procedures (SOPs), Work Instructions and technical documents.
• Demonstrated excellence in customer service (internal and external relationships).
• Strong Interpersonal communication, analytical and organizational skills.
• Proficient In Microsoft Office applications.
• Experience in a clinical research organization (CRO).
• Advanced degree and/or professionally relevant Quality, Regulatory or Clinical certification(s) from an accredited organization.

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.

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.