Job Description:

RESPONSIBILITIES:

Kforce has a client that is seeking a QA Lead in Burlington, MA.

Summary:
The Validation and QA Lead will be responsible for managing the validation activities, quality assurance processes, and regulatory compliance for pharmaceutical projects. The successful candidate will also be responsible for leading and mentoring both offshore and onshore resources to ensure successful project delivery.

REQUIREMENTS:

• Bachelor's degree in Life Sciences, Computer Science, Engineering, or related field


• Minimum of 8 years of experience in quality assurance and validation within the pharmaceutical industry


• Extensive experience working with Quality Management Systems (QMS) and tools such as Veeva or Trackwise


• Strong experience with validation processes and documentation, including IQ, OQ, PQ, and use of HP ALM for test management and traceability


• Experience managing external audits and ensuring regulatory compliance readiness


• In-depth knowledge of GxP, 21 CFR Part 11, and other relevant pharmaceutical regulations


• Excellent project management skills with the ability to manage multiple projects simultaneously


• Strong problem-solving skills and the ability to mitigate risks effectively


• Excellent written and verbal communication skills, with the ability to collaborate across different functions and regions


• Proven ability to lead and manage both offshore and onshore validation and QA teams

The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.

We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.

Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless
and until paid and may be modified in its discretion consistent with the law.

This job is not eligible for bonuses, incentives or commissions.

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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