Associate Director of Quality Systems

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

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:

As Associate Director of Quality Systems, you will provide strategic direction and oversight for Quality systems, tools and resources to drive compliance and mitigate risk for Ora's clinical operations activities. 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:

• 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 and Education 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 & 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:
  • 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.