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Senior Manager, Document Control

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Senior Manager, Document Control oversees document release, document change control, document approvals, the full electronic document management system, and records management for change and quality control. Additionally Corrective Action Preventative Actions and continuous improvement are part of the role as the Sr. Manager. The position collaborates with remote site Quality Departments and provides recommendations for enhancement of Standard Operating Procedure (SOP) workflows, quality systems management, and quality assurance related systems.

Key Responsibilities

• Manage day-to-day document control activities in support of the entire company.

• Manage and maintain Electronic Document Management System (ie. MasterControl, Veeva).

• Provide oversight to the training program and system (Cornerstone).

• Manage the quality system training program in accordance with regulations and internal procedures.

• Responsible for the management of regulated records including achieving and retention.

• Manage hard copy and electronic information storage and retrieval processes and systems.

• Provide system supports related to document control activities, such as Cornerstone.

• Manage Controlled External Standards processes and system.

• Administer and manage the document change system.

• Participate in defining and implementing improvements to current document control policies and processes.

• Lead backroom activities for external audits.

• Maintain all document control activities to FDA Quality Systems Regulation requirements, ISO 13485, ISO 15189, CAP/CLIA and state requirements.

• Provide Key Performance Indicators for management review.

• Supervise personnel and provide coaching, guidance, evaluation and hiring as needed.

• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s Degree

• 8+ years document control or engineering data related experience

• 8+ years of direct change control system management experience

Preferred Qualifications

• Advanced Degree (Master’s +)

• 3+ years in a supervisory control within quality control, quality assurance, or document management

• 3+ years of medical device industry experience

• Experience with:

  • Configure, Implementation and management of PDM / E Docs System
  • Change control, CAPA and deviation quality systems
  • Management Information Systems implementation

• Strong knowledge of:

  • SOP and Engineering specification creation and management
  • cGXP regulations and guidance
  • office application software

• Familiarity with GMP, 21 CFR Part 11, FDA GMP, MA & NYS regulations, CAP, CLIA

• Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem solving with departments and colleagues

• Track record of consistently meeting or exceeding project deadlines

• History of successfully managing multiple concurrent initiatives and maintaining one’s own workflow

• Demonstrated ability to work well under pressure while maintaining a professional demeanor

• Understanding of HIPAA and importance of patient data privacy

• Commitment to reflect FMI’s values: Patients, Passion, Innovation, and Collaboration

 

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

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