Quality Systems Specialist - Contract - Remote within US

Proclinical is seeking Quality Systems Specialist to serve as the Process enabler and support for critical quality processes including Deviations, Corrective and Preventive Actions (CAPA), Change Control, Regulatory Intelligence, and Training within a global biotechnology environment. This role is essential in maintaining quality excellence and regulatory compliance across the enterprise while ensuring processes remain efficient and fit for purpose.

Required Experience and Skills:

Bachelor's degree in Life Sciences, Engineering, or related field2+ years of experience in Quality Systems within biotechnology or pharmaceutical industries1+ years of experience in manufacturing, operations, or related business areasDemonstrated experience in process ownership and quality systems managementStrong understanding of GMP, GLP, GCP regulations and ICH guidelinesExperience with electronic quality management systems (Veeva)

Preferred Qualifications:

Master's degree in related fieldASQ certification (CQA, CQM)Experience with Lean Six Sigma methodologiesInternational work experienceExperience with change management and organizational development

Key Competencies:

Strong process thinking and analytical skillsStrong experience in ExcelExcellence in project management and organizationOutstanding communication and presentation abilitiesProven ability to influence without direct authorityStrong facilitation and training skills

The Quality Systems Specialist's responsibilities will be:

Serve as global process support for Deviation, CAPA, Change Control, Reg Intel, and Training processesFacilitate analysis of Quality Systems metrics and performance periodicallyManage Quality Systems deviations and CAPAs, ensuring proper investigation, resolution, and preventive measureOversee Regulatory Intelligence assessments and maintain associated documentationFacilitate the Change Control Review Board and maintain associated documentationPartner with subject matter experts and business representatives to identify GxP training content needs and GXP curricula modificationSupport development of Quality related training contentSupport quality systems audits and regulatory inspectionsProvide guidance and support to site quality teams in process implementation

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDSCIC