Quality Systems Manager Job at Germer International, Blue Bell, PA

ekN4b2hRY0pWZm41cG1WYlV4dEVtL09sQXc9PQ==
  • Germer International
  • Blue Bell, PA

Job Description

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

Job Tags

Similar Jobs

YMCA of Greater Dayton

Enrichment Instructor - Dance Job at YMCA of Greater Dayton

Enrichment Instructor - DanceCoffman YMCASpringboro, OHPart-time/Non-Exempt$10.70-$12.84/Hourly*This position is forDays/Evenings after school, one-two Days/nights per week Teaching basic ballet, Jazz skills to ages 3-18. One-two classes per day*Position Summary:... 

Classet

HVAC Sales Professional Job at Classet

 ...Job Description Job Description Aire Serv is hiring an HVAC Sales Professional! At Aire Serv, we provide comprehensive training and the systems necessary for your success. We are known for our exceptional customer service, professional image, and Done Right Promise... 

Providence Health and Services

Registered Nurse - Providence St. Mary (1 Year Exp. Req.) Job at Providence Health and Services

 ...Registered Nurse Providence St. Mary (1 Year Exp. Req.) at Providence Health and Services summary...  ...nursing program, a valid Washington RN license, BLS certification, and at least...  ...serve in over 50 hospitals, over 1,000 clinics and a full range of health and social services... 

Talent Search PRO

Surety/ Construction Associate - Remote Job at Talent Search PRO

 ...Job Description Job Description This is a remote position with occasional travel required. All candidates must be licensed and based in one of the following states: Texas, Alabama, Arkansas, Colorado, Mississippi, or Oklahoma. Our client, an Am Law 200 firm, is... 

Palo Alto Networks

Remote Director, Business Value Consulting Job at Palo Alto Networks

 ...our personalized learning opportunities just to name a few! Job Description Your Career In this Director Business Value Consulting role, you will build value-based business-cases for cybersecurity investment, by leading cross-functional teams composed of...