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Manager, QA Compliance/Sr. Manager, QA Compliance

Manager, QA Compliance/Sr. Manager, QA Compliance

ID 
2017-1084
Category 
Quality Assurance
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

This position is responsible for managing compliance programs at MacroGenics Inc. The individual will manage the quality system structure, manage the vendor qualification, change notification, and product complaint programs, and will interface with management at all levels to ensure programs are well executed. The individual will drive resolution to related issues and concerns, and communicate with supply chain, purchasing and to Sr. Management on a routine basis. This position will also supervise, coach and mentor one direct report.


Responsibilities and Job Duties:

  • Qualifies and maintains the qualification status of each contract manufacturer, contract testing laboratory, supplier and service provider.
  • Coordinates the scheduling and assignment of auditors and consultants to perform vendor audits of contract manufacturers, contract testing laboratories, suppliers and service providers within the Master Control systems.
  • Conducts audits of contract manufacturing facilities, contract testing laboratories, suppliers and service providers.
  • Prepares audit reports within the Master Control system and communicates any critical or major issues to QA Director, Sr. Management and end users. 
  • Monitors the corrective and preventive actions of contract manufactures, contract testing facilities and suppliers to ensure that deficiencies have been addressed and qualification status is maintained. 
  • Provides current approved vendors list to purchasing on a routine basis.
  • Communicates the discontinued use of a contractor or supplier when necessary and prevent use in the ERP system. 
  • Coordinates the cross-functional assessments of contractor and supplier change notifications. Manages the change notification program and ensures that appropriate responses are provided to contractors and suppliers as necessary. 
  • Maintains the quality manual. Oversees the quality system structure and ensures that content and policies wherein are current, accurate and reflects MacroGenics quality systems. 
  • Assigns audits and reviews audit reports from consultant for completeness prior to forwarding to the auditees. 
  • Recruits, trains and mentors new employee, and manages performance review for one direct report. 

Qualifications

Education:

 

Manager, QA Compliance:

 

BS Degree in a related field with a minimum of 8 years of experience in quality assurance or compliance. 

 

Sr. Manager, QA Compliance:

 

BS Degree in a related field with a minimum of 10 years of experience in quality assurance or compliance.

 

Experience:

  • At least 5 years of experience in a life science GMP regulated manufacturing facility
  • Hands-on extensive experience performing external quality audits.
  • Hands-on experience writing comprehensive audit reports, and SOPs.
  • Hands on experience communicating and resolving issues with contractors and suppliers.
  • Prior experience in a commercial environment.
  • At least 2 years previous experience as a supervisor with direct reports 

Knowledge, Skills and Abilities: 

  • Demonstrated knowledge of and ability to manage a vendor qualification program.
  • Demonstrated knowledge and understanding of quality systems.
  • Must have excellent interpersonal and people management skills.
  • Must be able to manage multiple projects at once.
  • Must be able to travel up to 40%.
  • Proficient using MicroSoft Office, specifically with MicroSoft Word, Excel and Powerpoint.

Supervisory Responsibilities:

One QA Compliance Specialist

 

Preferred Qualifications:

  • American Society for Quality (ASQ) certifications a plus.
  • Prior experience with Master Control preferred.

 

 

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.