Deviations/CAPA Manager Quality Systems IV

Integrated Resources Inc.; Lexington (MA); On-site; USD 100,000 - 120,000; Full time

Job summary

A specialized healthcare solutions provider located in Lexington, MA is seeking an experienced Deviations/CAPA Manager. The role involves managing global event management processes and ensuring compliance with GMP regulations. Ideal candidates will have at least 5 years of quality experience, a Bachelor’s degree in a science field, and ASQ certification. This position demands strong expertise in deviation systems and a collaborative approach across teams.

Qualifications

• 5 years of quality experience in deviation systems is required.
• Experience with Medical Devices, Biologics, and Blood Products is advantageous.
• Ongoing training in event/deviation management is essential.

Responsibilities

• Support the Quality Lead for Deviations/CAPA as a Subject Matter Expert.
• Manage Client’s GEMS Expertise Council and support regulatory inspections.
• Develop and deploy CAPA processes across the organization.

Skills

Quality management

Deviation systems expertise

Cross-functional teamwork

Regulatory compliance

Education

Bachelor’s degree in a science related field

ASQ Certified Quality Manager

Tools

GEMS systems

Quality monitoring software

Job description

Deviations/CAPA Manager Quality Systems IV

• Contract

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

About Client:

Client is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

Client is an equal opportunity employer. Client evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic

Responsibilities:

• Supports the Quality Lead for Deviations/CAPA as a Subject Matter Expert (SME) for the Client Global Event Management Systems (GEMS, Current and Legacy systems)
• Supports GEMS process and closure of legacy Client processes.
• Supports GEMS and legacy Client system metrics
• Responsible for supporting global event management processes and procedures (and others as necessary), by working with cross-functional working teams to develop and deploy CAPA processes that are standardized across Client and leverage best practices for business efficiency.
• Manages Client’s GEMS Expertise Council related to Legacy Client GEMS that is comprised of Network Event Coaches from each of the Network Event Review Boards (Plasma, Recombinant, Small Molecule, BioLife, and Distribution). Supports maintenance of an effective connectivity and related mechanisms among the Network Event Review Boards and Investigation teams. Supports customer feedback and system enhancements/ corrections.
• Responsible for preparing and providing training and/or supporting corporate and facility training for the GEMS procedures as developed.
• Maintains expertise in event/deviation management through ongoing training and participation in industry associations.
• Understands and assures conformance to Global GMP requirements and regulations. Interfaces with regulators during regulatory inspections.
• Support integration of Deviation/CAPA systems as required by management.

Education & Experience Requirements:

• Minimum of a Bachelor’s degree in a science related field plus 5 years quality experience in deviation systems
• ASQ Certified Quality Manager
• Experience with Medical Devices, Biologics, Blood Products, and small molecules