Mgr I, Quality (Documentation)

Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
The individual holding this position is responsible for managing document and change management activities related to the Medication Delivery Division. This individual is specifically responsible for the following activities:


1. Develop and manage the day-to-day document change control process for creation and revision of procedures and specifications for Medication Delivery, in accordance with Baxter procedures and regulatory requirements.


2. Work directly with Medication Delivery Quality Systems Manager and other stakeholders to write, edit and facilitate approval of division procedures.


3. Serve as liaison between Medication Delivery Business Units/Manufacturing facilities and Corporate Documentation & Data Management Team for activities related to periodic document review and document consolidation/reduction initiative.


4. Summarize and address comments from manufacturing facilities and business units as it relates to Medication Delivery procedures


5. Work directly with Medication Delivery Training Manager to develop specific training on procedures/processes


6. Manage the Medication Delivery Quality Record Center; ensuring quality record documentation is compliant with internal procedures and regulatory requirements


7. Provide general support to technical organization in drafting or reviewing summaries of data and other reports (e.g. supporting documentation for CAPA files)


8. Manages coaching, training, and development of subordinates


9. Provide support during internal and external inspections


10. Provide general quality support as required by management


Qualifications
QUALIFICATIONS:

Thorough knowledge of Device/Drug GxPs, and ISO standards
Ability to read, understand and concisely convey technical document content (technical writing background preferred)
Demonstrated ability to think critically/problem-solve
Strong computer skills required (all Microsoft Office applications)
Ability to manage multiple projects

Good interpersonal/communication/influencing/negotiation skills.



EDUCATION/EXPERIENCE:

Bachelor's degree in technical discipline
Minimum 5 years experience in pharmaceutical/medical device industry, including 1-2 years supervisory experience
Direct experience dealing with Document Control systems
Prior experience interfacing directly with FDA and other regulators strongly desired


As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits.




To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V