Job Details

5959 - GxP Quality Auditor / Senior Quality Lead

Description

Veristas 500 experts team up with the worlds most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the worlds most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

GxP Quality Auditor / Senior Quality Lead Responsibilities:

• Lead coordination between site and global teams to align SOPs and bracketing strategy
• Provide regulatory and technical interpretation to ensure compliance with FDA, EMA, and HMRA
• Develop and defend bracketing justification for 4 traditional lines, 1 RABS, and 9 isolators
• Facilitate governance meetings, escalate risks, and provide status to site/global leadership
• Review and approve protocol templates, summaries, and reports for finalization

Requirements:

• Bachelors Degree in an industry-related field
• Minimum 7+ years industry experience
• Demonstrated experience developing pharmaceutical bracketing and matrixing strategies
• Demonstrated experience maintaining FDA, EMA, and HMRA compliance
• Experience in a pharmaceutical / FDA-regulated manufacturing environment
• Working knowledge of cGMP and facility/equipment validation requirements
• Ability to write clearly, concisely, and persuasively in a professional environment
• Demonstrated ability to interact effectively with all levels of the organization
• Ability to work as part of a cross-functional team
• Strong problem-solving, critical thinking skills, and attention to detail
• Ability to work on-site, full-time, in Greenville, NC

Verista is an equal opportunity employer. National (US) Range $87,780 - $145,307 USD

Why Choose Verista?

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance.
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement