Director, Quality Assurance Client Engagement

Clario is a 50+ year old company that delivers industry leading clinical trial endpoint technology solutions. The future of clinical trials is vibrant, with new technologies revolutionizing what’s possible. From new trial modes to faster and integrated evidence and findings, our innovative clinical trial solutions mean we can unlock better evidence.

What We Offer

• Flexible work schedules
• Medical, dental, and vision insurance beginning Day 1 of employment
• Flexible work schedules
• Attractive PTO plan
• Engaging employee programs
• Remote work environment
  
  

What You'll Be Doing

• Responsible for contributing to both the strategic and tactical client relationships.
• Also focused on facilitating internal activities related to client commitment or needs. Acts as a liaison between multiple client stakeholders and internal functions to advocate for client needs and priorities. Works to align quality strategies within assigned areas of responsibilities.
• Contributes to the overall Clario Quality Management System (QMS) through effective application of quality policies, objectives and the analyses of data including quality indicators, audit findings and corrective/preventive actions.
• Trending for client specific purposes within product or service lines, but also across products and service lines where client needs require such focus.
• This includes supporting trending analysis, client governance participation, QA to QA and QA to outsourcing / relationship management needs. Partnering individual teams responsible for the execution of assigned QARA programs such as Risk Management, Internal/Vendor Audit Program, Client Audit Program, Technology and Information Quality, Issue and Complaint Management, Regulatory Affairs, Inspection Management and GxP Compliance. Responsible for interfacing with Senior Leadership, internal stakeholders, clients and client auditors.
  
  

Essential Duties And Responsibilities

Establish, implement and lead strategic, quality, operational and outsourcing imperatives of Clario clients. Acting as the Quality Assurance and Regulatory Affairs advocate for client needs. Supports client needs where appropriate, setting appropriate QMS expectations and acting as the Quality Assurance voice of customer internally and Clario Quality Assurance voice to select clients. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include may include interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems and providing guidance and counsel for career development. Effectively collaborates with internal and external stakeholders to identify and prioritize QA related customer initiatives. Supports the preparation and/or review of quality documentation and information including documentation on individual study performance, program and portfolio level performance, CAPA reports, quality metrics, etc. Continually works to improve the effectiveness of the QMS through the effective application of quality policies, objectives, audit results, analyses of data, and corrective/preventive actions. Model leadership behaviors and continuously improve leadership and relationship building skills.

Other Duties And Responsibilities

May interact with industry groups such as presenting at conferences or writing papers for publication.

The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract.

Education

QUALIFICATIONS AND SKILLS NEEDED:

• Bachelor’s Degree or equivalent experience
  
  

Experience

• Minimum 8-10 years’ relevant experience.
• Strong leadership and communication skills
• Extensive knowledge of global GxP standards with an emphasis on GCP, including but not limited to ICH, FDA, EMA and related compliance requirements specific to global geographic areas including – US, EU, APAC, etc.
• Extensive experience contributing to and understanding audit activity and CAPA or compliance management in the pharmaceutical drug development, biotech and medical device industries
• Excellent organizational, interpersonal, verbal, and written communication skills.
• Ability to work effectively as part of an integrated project team, while also taking ownership of assigned tasks to successfully achieve explicit delivery dates and milestones.
• Ability to travel up to 25%.
  
  

Clario is an equal opportunity employer.  Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.