Documentation Center Manager

Lake County, Illinois, USA
May 25, 2018
Required Education
Bachelors Degree
Position Type
Full time
The Sr Manager Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. This role will develop and support the strategic direction to ensure business objectives are met by managing large and/or complex initiatives. This position will also translate strategy into tactical objectives to deliver strategic plans and regulatory updates. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from supplier and TPM management to raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.


  • Ensure proper development, integration and support of quality regulations: drug, biologics, device and/or combination products.
  • Responsible for initiation, selection, coordination and management of quality systems projects. Lead project teams and/or direct staff in planning, preparation, review and approval of quality documentation.
  • Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, device and/or combination products including compliance with Corporate policies, processes and procedures.
  • Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
  • Manage and oversee the interrelated function activities including design control with R&D, Manufacturing Science and Technology (MS&T), Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs.
  • Lead quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.
  • Oversee new product introduction for pharmaceutical products, biological products, medical devices, or combination products. Support design changes to existing medical devices and combination products.
  • Interact with internal and external partners for development of best practices in our quality systems and procedures.
  • Review assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
  • Oversee the implementation and management of training and education programs for various aspects of quality assurance.
  • Global lead the Quality System Center of Excellence (COE) for documentation for Operations function. Must have good fundamental understanding of GxP documentation requirements and practices globally as they apply to biologic, pharmaceutical, medical device and combination products.
  • Performs day to day management of staff and oversees a team of 10 to 15 staff members to complete change request and document updates for our quality systems and product specifications.
  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Develops understanding of business documentation processes.
  • Engages site management to understand key business drivers and aligns key initiatives, to the extent possible, with these drivers.
  • Ensures alignment between IT solutions and business processes.
  • Develops staff to achieve organizational effectiveness.
  • Communicates appropriately with the sites to ensure their engagement and alignment with key strategic and tactical initiatives.
  • Works with IT groups to ensure requirements of business processes are understood
  • Drives implementation of global solutions.
  • Drives implementation of policies and procedures to maintain compliance to global regulatory requirements for policies, processes, and procedures.
  • Must have demonstrated leadership and project management skills
  • Ability to work cross functionally and cross culturally
  • Business Owner for the Documentation IT system (attache). Key Operations Opinion leader on Documentation and Documentation practices and also works closely with R&D and RA documentation functions.

  • Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area.
  • 10+ years' experience in quality assurance, quality oversight or relevant experience.
    Proven managerial leadership of technical professionals and/or in leading cross-functional teams.
  • Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
  • Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
  • Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
  • Experience working and/or managing in both team setting and independently. Works well with minimal manager guidance while able to manage own time and/or teams effectively.
  • Strong oral (with all levels of management) and written communication skills needed.
  • Excellent interpersonal skills a plus.
  • Can create strategic plans integrated into the overall quality system to deliver large and complex programs or projects.
Preferred Experience:

  • Knowledge of regulations and standards affecting: Device, Pharmaceutical, Biologic and Combination product business.
  • 5 - 10 years documentation management or quality system experience.
  • 5-7 years in with Management experience.
  • Bachelors Degree in Science or Technical Field.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled