Manager, Quality Systems
AbbVie
1 month ago
Remote friendly (Worcester, MA)
United States
Operations
Responsibilities:
- Implement and maintain the effectiveness of the quality system, aligned with corporate policies, processes, and procedures.
- Design and optimize quality systems, procedures, and processes with cross-functional teams for compliance and efficiency.
- Lead project teams in planning, preparation, review, and approval of quality documentation.
- Develop, author, review, and maintain Quality Agreements with clients, suppliers, and laboratories to ensure clear expectations and regulatory compliance.
- Lead the authoring of Periodic Quality Reviews to evaluate process performance and identify improvements.
- Participate as the site representative for Quality Agreement and Periodic Quality Review global Center of Excellence teams.
- Review and approve technical reports and memos for accuracy, completeness, and compliance with corporate and regulatory requirements.
- Ensure proper integration and support of quality regulations.
- Engage with internal and external partners to develop best practices in quality systems and procedures.
- Assess compliance, identify gaps, and drive improvements within the quality system.
- Exhibit exceptional attention to detail and a strong drive for improvement.
Qualifications:
- Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area (preferred).
- 8+ years’ experience in quality assurance, quality oversight, or relevant experience.
- Leadership experience leading technical professionals and cross-functional teams.
- Technical knowledge in Quality, Regulatory, Process Sciences, and Manufacturing Operations.
- Familiarity with product, process, equipment, and facilities for pharmaceutical, biological, or device-related products.
- Knowledge of QA systems and GMP compliance requirements (including regulations/standards affecting devices, biologics, and pharmaceuticals).
- Experience working both in teams and independently; able to manage own time with manager guidance.
- Strong oral and written communication skills.
- Excellent interpersonal skills (plus).
- Ability to lead medium to larger projects with increasing complexity.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible to participate in short-term incentive programs.
- Implement and maintain the effectiveness of the quality system, aligned with corporate policies, processes, and procedures.
- Design and optimize quality systems, procedures, and processes with cross-functional teams for compliance and efficiency.
- Lead project teams in planning, preparation, review, and approval of quality documentation.
- Develop, author, review, and maintain Quality Agreements with clients, suppliers, and laboratories to ensure clear expectations and regulatory compliance.
- Lead the authoring of Periodic Quality Reviews to evaluate process performance and identify improvements.
- Participate as the site representative for Quality Agreement and Periodic Quality Review global Center of Excellence teams.
- Review and approve technical reports and memos for accuracy, completeness, and compliance with corporate and regulatory requirements.
- Ensure proper integration and support of quality regulations.
- Engage with internal and external partners to develop best practices in quality systems and procedures.
- Assess compliance, identify gaps, and drive improvements within the quality system.
- Exhibit exceptional attention to detail and a strong drive for improvement.
Qualifications:
- Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area (preferred).
- 8+ years’ experience in quality assurance, quality oversight, or relevant experience.
- Leadership experience leading technical professionals and cross-functional teams.
- Technical knowledge in Quality, Regulatory, Process Sciences, and Manufacturing Operations.
- Familiarity with product, process, equipment, and facilities for pharmaceutical, biological, or device-related products.
- Knowledge of QA systems and GMP compliance requirements (including regulations/standards affecting devices, biologics, and pharmaceuticals).
- Experience working both in teams and independently; able to manage own time with manager guidance.
- Strong oral and written communication skills.
- Excellent interpersonal skills (plus).
- Ability to lead medium to larger projects with increasing complexity.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible to participate in short-term incentive programs.