Job Description

One of our specialty pharmaceutical clients is seeking a permanent Quality Compliance & Systems Manager to join their growing team in Richmond, VA (relocation assistance offered). This role will be required to work in the office Tuesday-Thursday. The Quality Compliance Manager role is a key part of the global quality organization in establishing and maintaining Quality Systems and driving a “culture of quality”. This is a key role in creating strategic plans with cross functional stakeholders to improve compliance and reduce risk in the Pharmaceutical Quality System (PQS). This role’s focus will be to support the review and approval of all the GxP IT system change controls and validation documents, lead the product quality complaints process, and facilitate global Deviation and CAPA management to support the business. Other responsibilities include:

• Cross-functional influence to create strategic plans to ensure establishment and lifecycle management of a compliant Pharmaceutical Quality System (PQS) which contains over 100 cross-functional processes.
• Oversee and action GxP IT systems change controls and validation documents such as quality assurance plans, test scripts and other documents as required; also supports technical transfer, testing, qualification and validation.
• Write, review and/or approve validation protocols and reports.
• Provides GxP IT support for reviewing and approving IT change controls quality assurance plans and other validation records.
• Act as a process owner for Quality Management System processes.
• Act as IT system Superuser (if the process uses an IT system) and able to support and advise on IT system changes and carry out execution of test scripts when required.
• Provide direct oversight and influence for the PQS processes (where the Quality Systems team does not have Process Ownership) and work with stakeholders to identify and rectify compliance gaps and improvements.

Qualifications:

• Bachelor’s Degree in a related scientific field
• Minimum of 8 years of pharmaceutical quality control and quality assurance work experience
• Extensive experience with either Veeva or Trackwise
• Computer System Validation (CSV) experience
• Experience with customer complaints, deviation investigations, risk assessments and CAPAs

Salary: $120,000-$135,000 + 15% target bonus (flexible based on experience)

Hours: Monday-Friday, 8:00am-5:00pm EST

Hybrid Schedule : 3 days onsite & 2 days remote a week

Hiring Method : Full-time direct hire opportunity

Benefits Include: Relocation assistance, 20 days of vacation plus floating holidays and sick leave, 401(k) and profit sharing plan, tuition reimbursement, comprehensive medical, dental, vision, life and disability coverage and more.

Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Job Tags

Permanent employment, Full time, Work experience placement, Work at office, Remote work, Relocation package, Monday to Friday, Flexible hours, 2 days per week,

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