Daniel Whalen Email & Phone Number

Lake Villa, Il, Us

Provide quality oversight for external manufacturing and cGMP activities. Conduct audits of suppliers, laboratories, and contract manufacturers. Develop appropriate QMS for biologic drug and medical device organizations. Perform quality assurance activities for processes such as labeling, warehouse, distribution, change control, CAPA, deviation, lot release, confirmatory testing, product complaint reporting and handling, supplier management, training, and other quality management systems.

Head of Quality for start-up organization, created organization quality system and responsible for overall compliance of cGMP activities and their associated processes to FDA, Health Canada, and Australia TGA requirements.

Basel, Baselstadt, Ch

Quality leader of supplier management responsible for auditing, qualifying, monitoring, problem resolution, and continuous improvement of components, raw materials, and services vendors.

Raleigh, Nc, Us

Quality Manager responsible for external Contract Manufacturing Organizations (CMO) and other suppliers used by Merz North America. Resolved supplier issues and led continuous improvement projects.

Deerfield, Illinois, Us

Quality Manager at Baxter’s Daytona Beach, FL facility and US and Canada Field Service operations. Responsible for quality performance for improvement, initiating and completing field actions, implementing design control methods, executing product and process change assessments, corrective and preventive actions, management reviews and audit readiness.Successfully led integration of acquired businesses into Baxter’s Quality Management System, implementation, prepared and submitted fequired annual FDA submissions, prepared 483 response documentations, and led the facility Corporate Audit CAPA response.

Deerfield, Illinois, Us

Commodity Manager for electro-mechanical parts, design services and remanufacturing services; responsible for supplier qualification and inclusion on Baxter’s Approved Vendor List, auditing suppliers to industry and regulatory requirements, tracking quality performances, and approving supplier requests for change. Authored Baxter Supplier Quality Standard that defines supplier requirements of Baxter. Created Baxter’s Production Part Approval Process (PPAP) used to approve high risk electromechanical parts.Developed strategies to engage strategic suppliers, prioritize supplier qualification effort, and resolve supplier related issues. Led work teams to communicate Baxter’s concerns and expectations, enhance supplier change plans and corrective action report submissions.

Hanover, De

Provide quality leadership in all phases of product life cycle from initial product conception through post launch field support. Met regularly with executive leaders to report hardware and software development status, escalate risks and resolve resource issues. Lead teams through the 8D/CAPA problem solving process to implement containment, corrective and preventative actions. Lead teams through requirements analysis to ensure the Voice of the Customer was incorporated into product designs. Perform compliance audits to internal, ISO and customer requirements.

Chicago, Illinois, Us

Automotive, Communication & Electronic Solutions; Deer Park, IllinoisCoordinated the development, implementation and continuous improvement of a stage-gate product development and launch process. Continuously defined quality system requirements based on customer, industry and company requirements. Utilized a blended training strategy to create and deliver training to educate employees on Program Management, the New Product Launch process and its tools. Lead requirements generation, testing of the application, development of training courses and handouts for an electronic document control system for records and managed its deployment.

Chicago, Illinois, Us

Integrated Electronics Solutions Sector; Deer Park, IllinoisLead training operations for Integrated Electronic Systems Sector, negotiated contracts and tracked costs. Coached the Motorola Computer Group and Energy Systems Group to identify and provide learning resources.Authored project manager and design team leader competency levels for the Automotive Group. Member of Corporate Engineering Learning Team developing competency based curriculums for 24 Motorola job functions.

Arlington, Virginia, Us

Served in numerous leadership positions and operations assignments.• Awarded Bronze Star as Tank Platoon Leader during Operation Desert Storm.• Established a Train-the-trainer program for 200 people to teach effective assessment and evaluation techniques of field training programs.• Authored and presented monthly status report to estimate current capabilities and forecast future needs for personnel, equipment, training and supplies.