Abbott Jobs in USA- Manager, Document Control Job Vacancy

Job Title : Manager, Document Control
AutoReqId 108968BR
Job Family Quality Assurance
Job Category Full-Time
Job Classification Experienced/Established
Division Abbott Diabetes Care
Shift First
Relocation Assistance None
Overview
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.  The company employs approximately 91,000 people and markets its products in more than 130 countries.

Job Description PRIMARY FUNCTION:
Development and maintenance of systems within the Document Control and Data Management functions. Maintain the PLM (Product Lifecycle Management) database, which houses the DMR and QSR data. Development and maintenance of the controlled pre-Archive document storage file room in compliance with corporate policy on records retention and management. Oversee the Change Control process, which manages all Product and Quality Systems Documentation. Ensure the Change Control Process is in compliance with 21 CFR Part 820 & part 11 regulations and ISO 13485. Provide strategic quality, technical, compliance leadership and direction to the Document Control team and other division departments. Provide strategic quality, technical, compliance leadership and direction to the Document Control team and other division departments.

MAJOR RESPONSIBILITIES:
Provide support to new product teams offering guidance in product structure and document requirements. Ensure Document Control Support, i.e. staffing in ready room during audits to ensure timely identification and retrieval of necessary documentation. Determines the organizational structure and staffing needs to achieve business objectives, compliance and regulatory requirements. Author/update Quality System policies and procedures as needed in order to ensure compliance. Owner of the SOP on SOPs and Periodic review process ensuring Quality System documents are reviewed on a regular basis. This involves notifying document owners that review is needed and initiating ERs when timely action is not taken. Responsible for the administration and Management of the on-site pre-archival document storage process. Participate as a decision maker on the Governance Change Control Team and propose, create, analyze and approve software configuration changes to the PLM system. Maintain document archives consisting of DHFs, DHRs, artwork proofs, supporting data for executed protocols and associated media. Business Process owner of the electronic PLM (Product Lifecycle Management) system. Oversee configuration (continuous improvement) of the PLM to fulfill the business at all the ADC Manufacturing sites. Plan for, schedule, manage and provide support for Agile software upgrades, service patches. Assist in expanding the use of Agile software to increase efficiency of Document Control processes. Identify and recruit staffing and resources to support the Quality System for document Change Control processes, for multiple product lines deemed critical to the success of the financial performance of the Division. Develop strategies, establish and implement processes to tackle site and/or division wide issues for the efficiency of Document Control processes Delegates responsibility and authority to department staff on the basis of workload and opportunities for development. Monitors progress ensuring deadlines are met and results achieved. Develop and maintain PLM and other departmental metrics regarding volume, approval time, departmental processing time.

Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management
Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent representation.

ACCOUNTABILITY / SCOPE / BUDGET:
Accountable for overall compliance of the Change Control Process within the QSR, ISO standards, 21 CFR 820 & part 11 relating to Document and Data Control. Accountable for the proper and efficient functioning of the Agile PLM system which encompasses the Product record and the Quality System Documentation. Reports to the Division Director of Quality Systems. It is expected that the individual will have frequent interaction with Division level management with Executive responsibility and therefore requires high levels of competence, confidence and and credibility. The individual is a primary contact during FDA/ISO and other third party inspections. The individual is accountable for ensuring that the periodic review of Quality Systems documents is performed on a timely basis and compliant basis.
Skills/Experience Requirements Basic Qualifications:
Five years plus years of Management related experience in medical device or pharmaceutical environment. Managerial experience with Document Control and Change Control systems in a regulated environment, preferably medical device industry preferred.

Knowledge of Quality Systems and experience with 21 CFR 820 and CFR Part 11, and ISO 13485. Prefer minimum 3 years experience with PLM software including implementation and administration of an eDocument control system. Excellent interpersonal skills. Excellent oral and written communication skills Excellent problem solving and continuous improvement skills.