Reporting directly to the Senior Director of Global Quality Assurance, the Manager of Quality Systems leads and supports the development and implementation of Abiomed’s quality system and compliance programs. Additionally, this position will assure all aspects of the company’s Quality System are in conformance with customer, international and domestic requirements. This role directs multiple Global Quality Systems functions, including but not limited to: Corrective and Preventive Actions (CAPA); Complaints; Quality Improvement Program; Training; Management Controls including Management review and Quality Planning; Quality Systems Metrics and Trending - Global Key Performance Indicators (KPIs). Internal and External auditing programs.
Principle Duties and Responsibilities:
Manages and evolves Abiomed’s Global Quality Management Systems (QMS), including the development, continuous improvement and implementation of key quality system processes – including leading efforts to develop requirements, validate and implement the electronic Quality System Management (eQMS)
Assures compliance to Quality System policies and procedures to ensure compliance with the applicable domestic and international regulations/standards
Designs and implements effective quality processes including procedures, documentation systems, CAPA, complaints, tools, reporting metrics and measurable improvements that are required to meet quality system standards and customer requirements
Reviews and presents the state of the quality system on a routine basis to management
Develops and manages the Global Internal Audit Program, in conjunction with Sr. Director QA/QC. This includes the process for planning Internal audits and tracking/trending audit results, developing and monitoring audit schedules, execution of audits, review and issuance of audit report documentation and determining adequacy of corrective actions resulting from audit findings and report to Senior Management – including the planning and implementation of Global Mock audits and remediation activities
Manages the Corrective Action & Preventive Action (CAPA) Program to assure CAPA effectiveness and works with department leaders to assure timeliness of response to assigned CAPAs within required target dates
Manages document control processes and systems for GMP/GCP activities in compliance with internal procedures and policies as well as regulatory requirements – including the routing, review, approval, distribution and archival of new and revised controlled documents to support quality system requirements
Assures controlled documents are periodically reviewed for relevance and accuracy and that actual practices are reflected as defined in applicable procedures
Establishes and maintains records management system including secure storage, retrieval, retention and destruction
Manages Complaint Handling Team to ensure timely review and closure of complaints and adverse event reporting
Implements projects and policies to ensure that the complaint handling operation is compliant and efficient
In collaboration with Human Resources and relevant departments, assures an effective Quality System Training program for all related procedures/processes is in place and training is implemented and effective
Leads compliance support during FDA and other regulatory compliance inspections
Leads or assists in the formulation and execution of remediation efforts resulting from compliance inspections, FDA Mock Audits, including responses and implementation follow-up
Assists departmental management in the execution/implementation of projects, as requested
Skills/Requirements
BS Degree in a Scientific or Engineering discipline; MS preferred
Minimum of 5 years of experience in a GMP-related field within a biotechnology or biologics manufacturing facility
Minimum of 3 years managing and leading the Quality System and associated teams at the company or corporate level
Knowledge of global quality systems and regulatory requirements (21 CFR Part 11/210/211/820, ISO 13485, PAL)
Strong knowledge of GMP, SOPs and quality systems
Works on multiple assignments in collaboration with various department system owners
Advanced skills with MS Office applications (Word, Excel, Access) and Adobe Acrobat
Ability to communicate and work independently with scientific/technical personnel
Excellent interpersonal, verbal and written communication skills are essential
Excellent writing and editing skills
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Experience with FDA (or Notified Body) inspections
Certified for Lead Auditor, Internal/External Audits preferred
Ability to quickly grasp technology, medical applications and applicable regulations/standards
Ability to create and effectively communicate regulations/standards
Ability to positively influence groups across an organization to embrace a common philosophy
Ability to manage and execute on multiple, critical projects simultaneously
Strong ethics to escalate issues in the face of competing priorities
Ability to train and develop staff
ABIOMED is an Equal Employment Opportunity/Affirmative Action employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.
Please note that we do NOT accept unsolicited resumes or candidate referrals from recruiters and agencies that are not already on our preferred vendor list.
