Objective/Profile

Pharmaceutical professional with significant Quality Assurance experience is seeking a challenging role with an established manufacturing/packaging firm. Team player who is driven to satisfy internal and external customers. Has proven track record of successful FDA inspections leading to new product approvals. Possesses a detailed knowledge of the cGMP regulations and their application in the efficient manufacture of safe and effective drug products.

Professional Experien

Aphena Pharma Solutions, Cookeville, TN (2/2019-1/2020)

Contract Packager/Repackager of Branded, Generic Prescription, OTC, Nutritional Supplements, Veterinary products and Medical Devices.

Director of Quality and Regulatory Affairs

Direct the QA and Regulatory activities of a nineteen person team responsible for the compliance of two 24 hour/6 day packaging facilities.

Areas of Responsibility:

Responsible for FDA, DEA, and Third Party USP, VAWD and UL registration and compliance.

Represented Aphena Pharma Solutions during six customer, and one FDA (Nutritional Supplement 21CFRPart 111) site audits by regulatory agencies and customers.

Drive audit findings to resolution through CAPA with sustainable results.

Manage Internal cGMP compliance and Supplier Quality programs.

Responsible for TN Site Quality Metrics, KPI and reporting to Corporate Management.

Maintain and/or establish state board of pharmacy registrations for interstate distribution of drug products.

Partner with new and potential customers for the purpose of establishing “Quality to Quality” relationships.

Train Operations and Quality personnel in documentation practices and processes that are customer specific.

Monitor and maintain employee SOP and cGMP training for compliance.

Manage the TN site Quality Systems including: Complaint Handling, Non-Conformances, Unplanned Deviations, CAPA, Document Control, Annual Product Review, and Batch Release.

Manage department budget.

Septodont (Novocol, Inc), Louisville, CO (10/2016-8/2018)

Manufacturer and Contract Manufacturer and Packager of Generic Prescription and OTC topical Drug Products, Medical Devices, Dental Materials and Cosmetics.

Director of Quality Assurance

Directed the QA activities of a four person team responsible for the Compliance of a 24 hour/5 day manufacturing facility.

Areas of responsibility:

• Responsible for Louisville site FDA Drug and ISO 13485 Dental Device compliance.

• Represented Louisville Quality Assurance during site audits including two customer audits, four Notified Body ISO audits and one FDA Drug audit within a two year time period. Each audit outcome was favorable for Septodont.

• Managed internal auditing program for both ISO and cGMP requirements.

• Managed Louisville site Quality Systems, Metrics Reporting, Non-Conformaces, CAPA, Document Control, Annual Product Review, Batch Release, Recall program, and cGMP Training Program.

• Member of Quality Leadership Team comprised of Vice President of Global Quality and Directors from Septodont’s multinational sites.

• Partnered with Production and R&D for demonstration, stability and process validation batches for four new generic formulations to date, one of which was recently resulted in an ANDA submission.

• Represented Quality Assurance for the review of all site change control documents, and North American documents pertaining to the Louisville site.

Septodont (Novocol, Inc) continued from page 1

• Responsible for customer complaints processing and their respective investigations.

• Acted as US Agent for foreign subsidiaries.

PAR (Formerly Endo/Qualitest), Huntsville, AL (10/2002-2/2016) Manufacturer and Packager of Generic Prescription and OTC solid oral dosage, liquid oral dosage and semi-solid topical products.

Director of Compliance and Supplier Quality 12/2008-2/2016

Direct the QA activities of a four person department responsible for Corporate Compliance and Vendor Quality activities and associated budget for the Huntsville and Charlotte sites.

• Initiated and coordinated recalls and Field Alert Reports for the Qualitest sites. Acted as primary FDA contact from initiation through termination. Collaborated with MQA, R&D, Pharm Tech, QC and others in mitigating company risk in terms of the affected batches and future batches. Managed third party reverse logistics company activities with respect to recall mailings and product return. Communicated serious quality issues to Senior Management and stakeholders prior to and during market actions.

• Managed the supplier quality program for Qualitest suppliers of raw materials and components. Maintain audit schedule, and support purchasing, second sourcing projects and R&D. Negotiated and implemented meaningful Quality Agreements with vendors. Performed “for cause” audits as needed based on MQA Vendor Complaints. Coordinated with External Manufacturing Quality to align processes and procedures and develop synergies.

• Responsible for internal auditing program for the three Qualitest manufacturing sites and distribution warehouse.

• Established and maintained QA oversight in Distribution Warehouse. Ensure compliance with 21 CFR 205 warehousing requirements. Created vendor specification program to define expectations and enhance Quality review during receipt of materials.

Director of Quality Assurance 04/2003-12/2008

Directed all QA activities of three manufacturing facilities with three managers and fifty hourly employees responsible for Shop Floor Inspection duties, Documentation, Batch Release and Label Warehousing.

• Primary FDA contact through eight cGMP inspections at the different sites including multiple ANDA pre-approval (PAI) inspections. Attained post inspection Voluntary Action Indicated and No Action Indicated status for the facilities.

• Routinely lead interdisciplinary teams of senior management in each of three facilities for the purpose of addressing critical Quality concerns.

• Investigated and wrote or reviewed Manufacturing, Complaint, and Laboratory OOS Investigations and Processing Variances. Amended Processing Variance program to produce quantifiable data for use in Quality improvement efforts. Monitored CAPA and reported effectiveness to Plant Management.

Manager of Quality Assurance 10/2002-04/2003

Managed all Huntsville Tablets Facility MQA, Equipment Qualification and Process Validation activities.

Schering Plough, Miami Lakes, FL (2001- 2002)

Manufacturer and Packager of OTC solid and semi-solid dosage forms, prescription antibiotics for re-constitution and trans-dermal nitroglycerin patches.

Operations Manager

Managed Manufacturing and Packaging activities with seven direct reports including, Production Supervisors, Support and Engineering staff in a three shift environment. Overall responsibility for one hundred plus hourly and salaried employees and plant performance.

Education / Professional Development

BS, Business, University of South Florida, Tampa, FL

Certificates: Schering Plough Management Development Program in Association with University of Miami, ASQ Certified Quality Auditor and HACCP Auditor

Seminars: Automated Imaging Association: FDA Guidelines for Electronic Label Verification; Acuity Imaging: 2D

Matrix Symbology; Food and Drug Administration: FDA New Orleans District Pharmaceutical Training; FDA MedWatch Program Launch; DuPont: Injection Molding Basics; Customer Centricity Training (Disney model).

Professional Affiliations

Member, ASQ

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