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5478 - Senior Quality Lead/ Manufacturing CSA QA

Philadelphia, PA

Description

Verista’s 500 experts team up with the world’s 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 world’s 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

Senior QA Lead / Manufacturing CSA QA Responsibilities:

Key Responsibilities:

  • Has understanding of regulations pertaining to the implementation and use of computerized systems in all GxP areas
  • Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on FDA CSA.
  • Develop and Present the Quality Assurance Plan for a large multi-year manufacturing site based on FDA CSA approach.
  • Consults with Quality team members and relevant internal stakeholders to identify / define high risk areas with the intent on focusing on patient safety, product quality and data integrity
  • Identifies and escalates areas of risk or non-compliance to manager / leadership team
  • Provide support to regulatory inspection preparedness activities as needed

Requirements:

  • Bachelor's degree and relevant GxP work experience
  • 11+ years' experience of relevant role experience
  • Resource must be a strategic, high-level thinker who knows CSV/CSA, and very strong in data integrity/ALCOA principles
  • Experience performing Quality Assurance function related to Computerized Systems / Infrastructure
  • Proficiency with regulations related to FDA / MHRA regulations
  • Experience with validation of Enterprise / Lab Computerized Systems
  • Quality metrics, dashboards, analysis and improvement programs
  • Ability to guide and ensure client compliance with industry best practices and regulations.
  • Proficiency in using Microsoft Office Applications

This is a hybrid role with onsite support requirements expected in Philidelphia, PA

 

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$87,780 - $151,463 USD

Benefits

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.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • 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

Verista collects and processes personal data in accordance with applicable data protection laws.  If you are a California Job Applicant, see the privacy notice for further details. 

For more information about our company, please visit us at Verista.com

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