Manager Quality

LINDA MIKULAN-MAXFIELD

**** ******* *****

Hoffman Estates, IL 60192

E-mail: ************@*****.*** Cell: 847-***-****

PROFESSIONAL EXPERIENCE:

Flex International, Buffalo Grove, IL March 2018 – Date

Director of Quality

Manage a staff of 125 plus permanent employees and 50 plus contract employees for: Quality Systems, Validations, Quality Engineers, Microbiology Laboratory, Dosimetry Laboratory, Supplier Quality, Metrology, Information Technology Business Systems and Filling Operations for contract manufacturing of medical devices and injection molded parts.

Leadership:

Collaborative, supportive, coaching and mentoring for teamwork across all areas of the organization.

Ability to identity, train and develop a diverse team that is flexible and adaptable to numerous business challenges: project scope changes, setbacks, and moving deadlines.

Corrective feedback given to team members when they need to modify their approach to achieve their goals.

Technical Skills:

Experience in responding to audit observations using the CAPA process: containment, correction, investigation, root cause analysis, corrective actions and effectiveness checks.

Quality System implementation for the molding, assembly, sterilization, packaging, associated equipment and software validation packages of a glucose monitoring device.

Quality System implementation for the start-up of E-Liquid products which included filling, blistering, and packaging with the associated verification studies

Business Development:

3 Successful Extension to Scope ISO 13485:2016 Audits in 2019: 1. Addition of a Temperature and Humidity Controlled Warehouse 2. Printed Circuit Board Manufacturing and Assembly 3. Microbiology Laboratory for Bioburden, Endotoxin testing, and the addition of three ISO 8 Clean Rooms with the associated environmental monitoring.

Member of the facility management team for the new customers, program implementation and site business activities.

Continuous improvement of the Quality System through Management Reviews. Internal Audit Program and Layered Process Audits.

Baxter Healthcare Corporation, Round Lake, IL September 2005 – March 2018

Corporate Quality, Supplier Quality Sr. Manager (September 2008 – March 2018)

Managed a staff of 10 permanent employees for: New Supplier Requests, Acquisitions & Divestitures, Due Diligence, Supplier Notices of Change/Decommissioning

Qualified Lead Auditor for Due Diligence, Drugs, Contract Manufacturing Organizations, Biologics & Medical Devices

Subject Matter Expert, and/or Escort for internal and external Supplier Quality audits

oCoordinated and responded to audit observations from: FDA, ISO, European Ministries of Health & Swiss Medic.

Global Process Owner for Supplier Quality/Purchasing Controls

oLed the Supplier Quality simplification to align with the minimum requirements of FDA, EU MOH, Canadian and Japanese regulations and ISO Standards which resulted in an average cost savings of 2 million dollars/year.

oDeveloped a New Supplier Request Review Board with purchasing input and decreased requests by 50%.

Global Team Leader for Material Controls to support the revamping of the Quality system and includes Manufacturing Materials, Receiving & Inspection, Reduced Acceptance Activities, Storage, Handling & Distribution, Product Returns and Product Holds

oThe Reduced Acceptance policy for certified items was revised for out-of-scope materials to having a Risk Assessment and the pilot site had a 2 million/year reduction of working capital for 2 materials

CAPA Owner for Internal Plant Shipments project that closed a Service Supplier compliance gap. The CAPA transferred the paper records for nonconformance, Change Control and Quality Agreements into the Supplier Quality database.

Primary Support for the 2008 Heparin Crisis which included Project Management for Securing the Supply Chain. The project revamped the Supply Quality system and instituted a Certificate of Analysis & Label Library for API in the facilities

Trained and implemented Lean Practices: Value Stream Mapping for Supplier Notice of Change, Visual Management Boards to Manage Workload, and Standard Work for Divestitures & A3 Problem Solving Tools.

Corporate Quality, Quality Systems Manager (January 2008 – September 2008)

Leader of the development & management of the architecture strategy for the Resource Management Chapter of the Corporate Quality Manual which included: Supplier Management, Purchasing, Material Management, Installation & Servicing, Training, Facilities & Equipment, Maintenance, and Storage & Distribution.

Coordinated & facilitated the approval of Supplier Quality Corporate Policies to meet the regulatory commitments & industry standards with measurement on effectiveness of deployment

Led the transitioned the Global Supplier Notice of Change project/protocol to a Corporate Quality Policy

Promoted to Senior Manager to be the primary support for the Heparin crisis.

Renal Division – Supplier Quality & Quality Systems (September 2005 – January 2008)

Lead Quality Auditor that included all aspect of supplier qualification & disqualification for domestic & international medical device suppliers following ISO 13485:2003, 21CFR part 820 & European Medical Device Directive which included: product/service quality, performance metrics, quality agreements & material specifications

Participated & provided approval for: Change Review Boards for Suppler Notice of Change, Supplier Corrective Action Reports, SCARS & procedure development & update

Developed & deployed a Non-Manufacturing Training Corporate Training Policy with cGMP/Quality presentation

American Pharmaceutical Partners, APP, Inc. – Melrose Park, IL June 1999 – September 2005

Corporate Quality Assurance, cGMP Training Manager (January 2001 – September 2005)

Staffed a Corporate cGMP Training Department for 7 employees in Illinois & 6 employees in New York which included the management of the Corporate Quality System for 21CFR part 210 & 211 job specific training & qualification. Responsibilities included: coaching the department members to execute protocols, deliver training & write supporting documentation

oImplemented a training program in an acquired European company which included: auditing the facility, creating a plan, hiring employees & mentoring.

oDevelopment of Corporate Policy, Procedures & delivering training that supported the successful implementation of Documentum electronic document management system

oCreated SAP requirements for User Rights Assignment and Rights Termination.

oProject Manager for global Learning Management software which involved the user requirements with a cross-functional team & securing 300K budget approval

oDeveloped a Price of Nonconformance for Chemistry that communicated the resources and spend need to investigate and disposition.

Provided monthly updates to the Company Strategic Enhancement Action Plan Steering Committee & FDA on the Training Action Plan & participated in FDA inspections.

oChemistry Out-of-Specification, OOS, testing was cited in a FDA 483. Developed core and advanced training modules for Chemists which resulted in a 70% decrease in OOS that was presented and accepted by the FDA.

Technology Transfer Leader (June 1999 – January 2001)

Coordinated plant issues with the project team to include scale-up processes, new equipment & procedures, equipment & process validation & manufacturing of stability batches for 7 ANDA submissions.

oHigh cost cancer drugs were failing the final filter testing. Worked with operations to develop a redundant filtration process which decreased the probability of a batch rejection due to post-integrity filter testing by 100%.

oDeveloped & implemented stability batch manufacturing & product validation protocols & associated final reports

oCoordinated plant documentation needed for CMC section of product submissions

oPromoted to cGMP Training Manager due to numerous Warning Letters and the need to partner with Lachman consultants

Sterigenics International, Inc. – Schaumburg, IL March 1997 – June 1999

Quality Manager (March 1997 – June 1999)

A new facility was opened in Illinois and the associated resources were transferred. The daily Quality activities were backlogged and the internal inspection 3 months after my hire was high risk. A follow-up inspection was performed 6 months later with zero observations.

Maintained, audited and implemented Quality Assurance sterilization programs in accordance with the objectives of Corporate Quality Assurance for the facility gamma irradiation process

oParticipated in the Corporate Audit and Management Review programs for the facility and coordinated all Corrective Action, Observations and follow- up responses

oResponsible for all aspects of quality that include: ISO 9001 Certification, plant tours, audits experimental protocols & Nonconformance

oResponsible for requalification protocol, coordination of data with the Nuclear Engineer & written final report after participation in the isotope loading and major requalification.

Convatec, St. Louis, MO April 1996 – March 1997

Critical Environment Sales Representative (April 1996 – March 1997)

Responsible for selling and providing the first line support for products used in clean rooms that included: Disinfectants, Sterilants & Skin.

Coordinated sales activities and trained VWR Scientific representatives to distribute Convatec products in Illinois, Indiana, Michigan and Wisconsin

Helene Curtis Industries, Rolling Meadows, IL March 1986 – April 1996

Group Leader of Microbiology (July 1991 – April 1996)

Management of 2 Microbiology laboratories with a total staff of 7: Chicago, IL - Microbiological testing for in-house and contract production & Rolling Meadows, IL - Preservation challenge testing, preservative development, & formula authorization.

oMicrobiological final product counts were increasing and additional preservative was not working. A resistant house gram negative microorganism was identified along with the development of a biofilm in the manufacturing equipment. A systematic disinfection of the facility resulted in acceptable microbiological counts and preservative levels returning to previous levels.

Represented Research & Development to Quality Assurance & Operations Department management. Communicated plant hygiene, product status, and corrective actions.

Member of the cGMP Steering Committee. Team activities included: designing and delivering cGMP Overview, SOP writing & Plant Hygiene training. Other activities included a mock FDA inspection, auditing of the manufacturing facility and long term planning activities.

Scientist (March 1986 – July 1991)

Performed microbiological testing for in-house and contract production.

Team leader for the development of a new preservative system for shampoo & conditioners

South Suburban Hospital, Hazel Crest, IL August 1981 – March 1986

Medical Technologist, Chemistry & Microbiology (August 1981 – March 1986)

Cultured, interpreted and identified clinical specimens for human pathogens.

Assisted in training Medical Technician students

Prepared, tested, and reported clinical laboratory samples for critical chemical values including: electrolytes, glucose and significant human enzymes.

Participated in the American Society of Clinical Pathologists testing program

EDUCATION:

Master of Business Administration, Rosary College (Dominican University) River Forest, IL 1993

Bachelor of Science in Medical Technology, Bradley University, Peoria, IL 1981

REGISTRATIONS:

American Society of Quality Manager/Organizational Excellence - Registration Number 9730

RABQSA Certified: ISO 9001:2000- 36 Hour Lead Auditor with Medical Device Focus (ISO13485) - Certificate # Q9797

American Society of Clinical Pathologist Board Registered - MT 142429

Honored Member of Biltmore Who’s Who Executive and Professional Registry

PRESENTATIONS:

Co-Presenter – “Joint Perspectives from IPEC –Americas and FDA-Excipient Risk Assessment for Change Notification, “American Association of Pharmaceutical Scientists in Denver, CO, November 13, 2016.

Presenter - “Auditing Suppliers in Emerging Markets,” Institute of Validation Technology, Annual West Coast Forum in San Diego, CA, September 13 – September 15, 2011

Co-Presenter - “Reducing Supply Chain Risk in Emerging Markets – Sourcing Practices at Baxter Healthcare,” Drug, Chemical and Associated Technologies Association, Meeting in Rosemont, IL, October 6, 2011

INDUSTRY AFFLIATIONS:

International Pharmaceutical Excipients Council (IPEC), Leader of Policy Committee, 2014 to 2018

International Pharmaceutical Excipients Council (IPEC), Executive Committee, 2012 to 2015

USA Pharmaceutical Industry Supplier Discussion Group, 2010 to 2015

COMMUNITY SERVICE:

Member of 100 woman who care that reviews and provides finical support to charities on a quarterly basis

2017 American Diabetes Association –Baxter Quality Assurance Captain for donations and walkers

Habitat for Humanity - House building team member

Feed My Starving Children – Packaging of meals for children in underdeveloped countries

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