Ann Dougherty has over sixteen years of experience in leading quality and compliance within the pharmaceutical, biopharm...
ANN M. DOUGHERTY
[email protected] Evergreen, CO 80439 Mobile: 720-878-4862
QUALITY COMPLIANCE COLLABORATION LEADERSHIP Innovative Quality Leader with a strong record of achievement seeking a long-term opportunity to drive a culture of quality and compliance across manufacturing operations. Over sixteen years of experience in leading quality and compliance within the pharmaceutical, biopharmaceutical, biotechnology, cosmetic and medical device industries. Skilled in quality management for trade and generic prescription drug, OTC, cosmetic, combination and medical device products. Experience in managing Quality Assurance teams to oversee all aspects of product manufacturing control and release to meet site operational goals. Interacted directly with domestic and international regulatory agencies in over 20 site regulatory inspections.
Core Competencies:
Failure investigation & CAPA Product Impact and Control Risk management Recall management Quality system reengineering Complaint management GXP auditing Cross-functional team leader Collaborative manager Positive change agent
PROFESSIONAL EXPERIENCE QUALITY ASSURANCE MANAGER/DIRECTOR
(2011-2014) QA Director, Consultant to Amedra Pharmaceuticals (through BioPoint Ltd, Inc.) (2013-2014) Provided consulting services to Amedra Pharmaceuticals Quality Assurance in the areas of: - Complaint system management and optimization for trade and generic versions of solid oral dosage products and combination products. - Annual Product Review authorship. Major Achievements: Reengineered the complaint management system to achieve a more robust, consistent and compliant process while elevating medical device system compliance.
GALDERMA LABORATORIES L.P, FORT WORTH, TX
(2010-2012) QA Management (2011-2012) Provided continuity of service and project completion to Galderma Laboratories Quality Assurance in the areas of: - CAPA system development and management - Label change control system reengineering - Recall management and closure - Quality Agreement negotiation with licensees and third party manufacturers Major Achievements: Reengineered the cosmetic and prescription drug label change control processes to achieve a more compliant, harmonized and streamlined label change control process. Incorporated a new electronic document approval system into the reengineered process to replace a labor-intensive manual process. Completed final product reconciliation and recall report for closeout and filing of a US-wide recall. Senior Manager, Quality Assurance (2010-2011) Managed professional staff (3), budgets and resources to drive compliance and continuous improvement of quality systems for oral dosage pharmaceuticals, topical dosage pharmaceuticals and cosmetics by: - Overseeing Quality staff managing product release, deviation investigations and material control. - Leading the customer complaint management system for all complaints received from the US market. - Directing manufacturing and packaging change control for all US-distributed Galderma products and generic products distributed by licensee partners. - Coordinating existing product release schedules and new product planning with Galderma Business Units and third party manufacturing sites. - Negotiating third party manufacturing and licensee relationships via Quality Agreements. Major Achievements: Promoted from individual contributor role to Senior Manager within a month of joining Galderma. With this promotion, took on all roles and responsibilities formerly held by Director of Quality for the site. Reengineered the product hold and release process to achieve a more streamlined process in order to more effectively and consistently meet production and supply chain targets. Implemented a CAPA system for the site. Managed a US-wide recall. Reengineered the recall process with lessons learned during recall implementation.
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Qualified and implemented an electronic document management system to more effectively manage SOPs. Co-managed a Texas Health inspection to successful closure with no observations. Lauded for evolving the QA team into a more cohesive and effective team by mentoring team members and consistently recognizing them for their contributions and expertise.
STRYKER COMMUNICATIONS, INC., FLOWER MOUND, TX
(2008-2009) Associate Quality Systems and Regulatory Affairs Manager (2009) Promoted to Manager of Regulatory Affairs with professional staff (6) to drive focus on compliance and continuous improvement for CAPA, recalls, complaint management, adverse event reporting and audits. Major Achievements: Appointed the Divisional CAPA Manager for three Stryker manufacturing sites. Developed plan for coordinating CAPA management, metric analysis and monthly senior management reporting for the three sites. CAPA Specialist, Regulatory Affairs (2008-2009) As site CAPA System Owner, drove continuous improvement and compliance to ISO 13485 and 21 CFR Part 820 by: - Driving the use of 4-Discipline Problem Solving Methodology to improve the quality of CAPA investigations and reduce or eliminate opportunities for failure recurrence. - Improving the CAPA system effectiveness through mentoring CAPA owners in best investigation practices, leading CAPA Review Board meetings, and fostering a collaborative team approach to CAPA investigations. - Leveraging the CAPA process to drive timely updates to risk assessments and design documents. - Providing CAPA investigation findings to R&D to enable incorporation of findings into the product design process. - Evolving metrics to better monitor compliance systems and apprise Senior Management of compliance issues. Major Achievements: Reduced open and overdue CAPA rates by over 45% within first eight months. In the ensuing six months a further 45% reduction was achieved while improving the quality and effectiveness of the CAPA process. Developed best practices in data analysis by partnering with Quality and Operations to define decision trees, trending and risk assessment methodologies. Resulted in a harmonized analysis approach across all product lines. Partnered with the Stryker San Jose, CA site to reengineer the CAPA system to achieve an effective, harmonized intersite process and to develop, validate and launch an electronic CAPA management system (Cebos). Presented the Stryker CAPA system to FDA and international agency auditors during three regulatory inspections. Nominated for Employee of the Month Award in both January 2009 and August 2009.
SYNDICOM, INC., DURANGO, CO
(2007-2008) Professional Services Manager Contributed to the growth of a software startup company serving the spinal medical device company via: Spearheading the mapping, optimization, implementation and maintenance of standard business processes for use of products supporting clients’ clinical research studies, clinical trials, and sales communities. Major Achievements: Co-managed a consulting project for a Fortune 500 medical device company, resulting in additional consulting projects based upon the findings and recommendations of the project.
CENTOCOR BIOLOGICS IRELAND LTD. (CBIL), RINGASKIDDY, CO. CORK, IRELAND
(2005-2007) Compliance Team Lead, Quality Assurance Hired as the company’s first Compliance Team Lead during startup of the greenfield CBIL (a Johnson and Johnson company) biopharmaceutical manufacturing facility. Managed the following aspects of the startup efforts: - Quality System process development and implementation to meet FDA and international regulatory requirements. - Auditing of analytical service, instrumentation, equipment, raw material and component suppliers to ensure compliance with Centocor global procedures and expectations of FDA and European regulatory agencies. - Review and approval of: IOQ protocols, protocol exceptions, validation plans, procedures, test transfer protocols. Major Achievements: Built and managed the QA Compliance Team (5 direct reports) to successfully meet tight project timelines. Teamed with Global Quality to develop a global Quality Risk Management System based on ICH and FDA regulatory risk management guidance. Developed a site hybrid quality-engineering change control system, resulting in a process that enabled leveraging of tests from commissioning into qualification, reducing time and resources required for testing. As Lead Auditor for the qualification of service, instrumentation, equipment, and material suppliers, led 21 supplier audits while leveraging audits to train QA personnel in auditing processes.
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Ensured all team members were qualified in ISO 9001 auditing procedures for equipment audits. Led multiple cross-functional project teams to drive the development and implementation of systems for deviation management, auditing and change control to assure compliance from equipment qualification through operational phase of facility startup. Auditing system was also leveraged for Sarbanes-Oxley site audits. Spearheaded a project to implement use of an electronic tracking system (TrackWise) at CBIL for documentation and tracking of deviations, investigations, regulatory commitments, changes and CAPAs. Partnered with local IT and Global Quality Systems to ensure system was compliant with local Irish regulatory requirements. Partnered with Document Control to build document control procedures and electronic management systems.
MERCK & CO., INC., WEST POINT, PA
(1998-2005) Manager, Global Quality Complaint Management (2004-2005) Promoted to role to drive divisional complaint handling compliance and to provide guidance to 24 Merck sites. Major Achievements: Spearheaded a project to re-engineer and expand the US customer complaints. Project resulted in implementation of new electronic complaint handling system (TrackWise) for more efficient complaint management across 24 Merck manufacturing sites. Authored Quality Systems Manual for complaint handling to provide ongoing guidance to 24 Merck sites. Developed best practices for worldwide complaint handling within global regulatory expectations. Analyzed and presented monthly complaint metrics from 24 Merck manufacturing sites to Senior Management. Reengineered complaint metrics to provide a more accurate gauge of the current state of compliance. Manager, Quality Assurance Complaint Unit (2002-2004) Managed a professional staff (12), resources and schedules to drive compliance of Global, US and Local site product quality complaint systems by: - Ensuring cross-functional investigation, corrective action follow-up, customer responses, and complaint trending was completed in a timely and effective manner. - Presenting the complaint management system to investigators during regulatory inspections. - Communicating complaint trend analyses from 24 Merck worldwide sites to Senior Management, R&D, Manufacturing and Quality to ensure data was available for product development and manufacturing decisions. - Directing the resources and processes for domestic complaint handling to ensure that product quality complaint data was accurately documented and disseminated to the appropriate Merck site for investigation. - Directing the establishment of site, regional and divisional annual complaint metric goals. Major Achievements: Spearheaded a project to integrate responsibilities for biological product quality complaints into the Pharmaceutical Complaint Unit. Successful project completion resulted in a single streamlined process requiring 4 less FTEs. Successfully initiated and directed a project that optimized and streamlined complaint handling processes for all Merck US and Puerto Rico sites responsible for managing complaints from FDA-regulated markets. Senior Quality Assurance Analyst (2000-2002) Researched and analyzed regulatory surveillance information for pharmaceutical, biotechnology, and medical device industries to identify and communicate to Senior Management emerging areas of regulatory focus. - Managed global quality metrics for compliance activities at 24 Merck Manufacturing sites. Presented the monthly metrics to Senior Management staff. Major Achievements: Contributed to the success of a Business Process Improvement Team by leading the development of critical requirement specifications for a web-based global metric reporting tool. Co-initiated development of a web-based audit tracking tool to replace multiple systems in use to track global manufacturing site agency inspections and audits. GMP Compliance Associate (1998-2000) Provided GMP Compliance support for R&D and Regulatory Affairs activities to ensure systems were within current regulatory expectations by: Auditing regulatory submission documents to support regulatory submissions and responses to regulatory agencies. Coordinating and executing audits of contract testing laboratories to ensure sites met regulatory requirements. Major Achievements: Contributed to FDA approval of four new products (FOSAMAX®, MEVACOR®, PEPCID® and CANCIDAS®) through audits of regulatory filing support documents as well as participation in product development teams.
ANN M. DOUGHERTY THE CE ADVANTAGE, INC., GROTTOES, VA
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(1996-1998) Owner/Consultant Founded consulting company to capitalize on need for analytical services utilizing capillary electrophoresis (CE). Major Achievements: As a consultant to the Merck Virginia manufacturing site, developed and validated a cost-effective analytical method to replace an expensive in-process assay. Collaborated with chemists at the Merck New Jersey site to develop analytical methods to support the transfer of a new manufacturing process to the Virginia site.
EDUCATION B.S. Biochemistry M.S. Biochemistry
Pennsylvania State University, University Park, PA Texas A&M University, College Station, TX
