Director, Product Quality Assurance

What you'll be doing: 

• 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. 
• 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.
• 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.

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. 

QUALIFICATIONS AND SKILLS NEEDED:

Education:

• 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 10%.

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.