Quality Systems Manager

Our pharmaceutical client is looking for a Manager of Quality Systems. You will be responsible for the overall Systems QA GMP functions at the site including compliance of the Quality Management System (QMS). Direct responsibility over: Document Control, Supplier Quality, internal/external audits, data integrity, and Medical Device functions. Ensure all GMP departments have procedures in place that are accurate, thorough, and compliant. Maintain metrics program with measurables that achieve continuous improvements of processes and procedures.

Essential Duties and Responsibilities

Manage day to day functions of the QA Systems team.

Mentor/coach and provide succession planning for the QA Systems team.

Oversee GMP compliance at the site including the Supply Chain, Facilities, Manufacturing, Packaging/labelling, Warehouse, QC laboratory, Validation, and QA groups. This includes compliance to 21 CFR parts 210/211, 11, EU, MHRA regulations/guidelines/directives

GMP compliance of the quality systems/tools used at the site including a quality manual, policies, procedures, and work instruction documentation that make up the hierarchy of the Document Control system.

Drive improvement of the quality, production, facilities/equipment, laboratory, material, and packaging/labeling systems through continuous improvement metrics and QbD (Quality by Design) programs.

Management of the Supplier Quality program to ensure GMP compliance over vendors that provide materials/services for the site.

Ensure the Document Control system is maintained such that all documents are controlled including, document/version numbers and effective dates.

Maintain and execute internal/external audit program including assuring site is “audit ready” at all times. In addition, provide assistance for any Regulatory Health Authority Inspections.

Management of the site Data Integrity program and ensure site is continuously monitored for issues including mitigation efforts.

Oversite of the Medical Device program with respect to the “Distributor” function.

Any other duties as assigned.

Key Competencies:

Demonstrated ability to evaluate quality matters by leveraging GMP experience, analyzing data, while using FDA Risk Based type approaches.

Attention to detail/ sense of urgency- ability to act quickly and escalate issues.

Experience in Trackwise, EDMS, LMS or other such software tools for managing the QMS.

Working knowledge of 21 CFR part 210/211, and part 11, FDA guidance. Knowledge of 21 CFR part 820 Medical Device Regulations preferred.

Education/Experience:

BA/BS (BS preferred) and 5 + Years’ experience in Pharmaceutical/Biotech