Fenwal is a global leader in medical technologies focused on improving blood safety and availability for patient care.  A $600+ million business, Fenwal is a growing company that develops leading products, services and technologies used to collect, process and store blood and its vital components.    Over 4000 people around the world work for Fenwal, helping each day to improve people’s lives while developing a rewarding career.

We currently have an opportunity for a Manager- Document Control & Compliance to manage and organize the document control process for the control of product and process-related information within the company.  

Responsibilities include:

• Manage the day-to-day change control process and provides direction for the creation and update of product and process-related data in accordance with internal procedures; ensure compliance with the FDA regulations and ISO requirements.
• Manage the overall direction for the creation and update of product and process-related data/documentation in accordance with internal procedures, FDA regulations, and ISO requirements.
• Proactively manage the organization to plan for and facilitate audits with internal and external auditors and minimize issues/findings.
• Continuously improves current business and system processes by creating, redefining, and maintaining standard operating procedures (SOPs) to ensure maximum efficiency in business and system processes; seek input on improved strategies and processes to help achieve goals; implement new processes and system practices to achieve the goal of reducing time to market for new products.
• Collaborate to identify/communicate common requirements for the PDM system; drive the development and implementation of PDM-related automation (i.e. electronic routing, approval, and distribution); provide direction on system upgrades.
• Oversee the management of user acceptance testing (UAT) for the PDM system; communicate PDM changes and ensure consistent communication and training for the PDM system across the functions and divisions; troubleshoot problems and generate solutions for users and customers of the PDM system.
• Develop and maintain effective communication and working relationships with internal customers; benchmark across plants to identify and support strategic new systems, leverage resources, and expertise to develop and implement Best Demonstrated Practices.
• Interact with manufacturing sites to assure system compliance and synchronization of data and documentation.
• Assist in the formulation of operation and capital budgets; manage department spending such that actual expenditures are within 10% of forecast.
• Develop and monitor various departmental metrics to improve departmental efficiency.
• Implement and monitor the SmartSolve employee training system.
• Manage the input of data into various parts and document databases such as Pilgrim to support the Quality System, product development and product implementation; ensure procedures are in compliance with standards and regulations.

Requires:

• Bachelor's degree preferred; extended training/certification in Configuration Management a plus
• 7 years work experience including 5 years supervisory experience in medical device and/or pharmaceutical  documentation control environment; experience managing a department that provides complete product-related data management to support product development, pre-production quality assurance, production and general operations.
• Knowledgeable in FDA and ISO requirements for document control
• Proven ability to communicate ideas and concepts, both verbally and in writing, to all levels of the organization
• Excellent collaboration and influencing skills
• Ability to act as a change agent and drive/influence change as well as effectively lead and motivate team members to achieve team goals
• Strong computer skills and knowledge of technologies being used by subordinates
• Self-motivated, good interpersonal skills and excellent analytical and problem solving skills.

Fenwal, Inc. offers an excellent salary and benefits package including immediate medical, dental and vision coverage, as well as life insurance, disability, 401K with company match and profit sharing.

Fenwal is an Equal Opportunity Employer. We encourage and support a diverse workforce.