Denea R. Conner Email & Phone Number

Tokyo, Jp

Torrance, Ca, Us

Seal Beach , Ca, Us

Manager, Quality Control Provided direction to a team of seven direct reports by building strong infrastructure within the department by communicating processes, goals, and expectations. Responsibilities include: management of raw material qualifications, environmental monitoring (EM) program, validation and technology transfer, in-process and final product testing, and contract lab testing. Key Achievements:• Managed Operational Excellence within the Quality department by using Dendreon Lean Six Sigma methodologies, in areas such as increase cycle time of QC testing, improved quality of documentation, reduction of waste streams.• Assisted with implementing key Quality systems in start-up facility ensuring departmental compliance and effective systems are established. • Developed standards, methods, and procedures for inspecting, testing, and evaluating the quality of products.• Oversaw and managed investigations for invalid assays, deviations, and OOSs along with developing supporting CAPAs.• Worked cross-functionally with Quality Assurance and Manufacturing departments to implement and manage procedures that ensured compliance with applicable regulatory agency (FDA). o As the Subject Matter Expert (SME), was the QC Microbiology point person during the Pre-Approval Inspection (PAI) and biannual FDA inspection. Used in-depth knowledge and experience to answer and address agency questions and concerns. • Maintained up-to-date knowledge of global health authority regulations, Federal Regulations, and International Conference on Harmonization Guidelines through formal notices and courses.

Thousand Oaks, Ca, Us

Manager, Quality Analytical Laboratory An experienced manager skilled in leading direct reports as well as cross-functional teams. Provided leadership, guidance, and coaching to direct reports to achieve business, Operational and Quality objectives and safety goals. Oversaw day to day operations of QC ES&S lab, supporting Manufacturing, Validation, PD and other groups.Key Achievements:• Owned and managed the Environmental Monitoring (EM), Compressed Gas, Utility sampling and Aseptic Gown Monitoring program, including planning, scheduling, protocol generation and executiono Accountable for EM and Utility sample collection, Endotoxin and Bioburden testing, along with regulatory adherenceo Represented QC on EM and utility forums, which have change control, NPI, audits, and site outage impact• Participated on bi-annual inspection readiness teams in preparation for regulatory audits with agencies such as FDA and EMEA in support of ARI’s EM and Utility programs • Led and represented ARI Quality on the following multi-site cross-functional teams:o Environmental Monitoring (EM) Family Method Training: As the project lead, worked in partnership with Microbiology site representatives to develop and implement an EM web-based training program for over 3,000 employees.o Japanese Pharmacopoeia (JP) Implementation: In support of the new JP requirement, partnered with Microbiology network to identify changes required by the JP and implemented water for injection guidelines in support of sampling and testing.

Director of SalesResponsible for generating revenue through direct selling of sales training programs to key pharmaceutical/biotech customers, along with driving new revenue through established client relationship management. Developed and delivered sales training presentations to Learning and Development managers for the purpose of increasing representative knowledge and exceeding sales objectives.

Client Services Manager Managed all aspects of pharmaceutical marketing and medical education, including, but not limited to; selling services to pharmaceutical clients, developing proposals, budgets, and managing all aspects of database development and advertising. Instrumental in increasing client account sales by 35% through effective relations management, account development, and proposal development and delivery.

International Marketing Medical Education ManagerGlobal responsibility for educating the medical community on the impact of disease awareness, women’s health issues, and establishing brand recognition. Successfully led multifunctional teams in the development of integrated marketing materials such as slide kit development, physician resources manuals, and creative sales materials. Pharmaceutical Sales Representative Account Manager, Southern Connecticut: Promoted Merck’s respiratory product and vaccine portfolio to pediatricians, internists, pulmonologists, and allergists. Improved disease awareness through the implementation of strategic health education programs, public awareness campaigns, and interactions with patient advocacy groups, key thought leaders, and healthcare decision-makers. Environmental Auditor Supported the Quality group by providing timely and efficient oversight of the compliance of the vaccine production areas in alignment with EPA guidelines. Monitored the facility, equipment, and personnel in accordance with the Emergency Planning and Community Right-to-Know Act (EPCRA) whose objective is to: 1) allow state and local planning for chemical emergencies, (2) provide for notification of emergency releases of chemicals, and (3) address communities' right-to-know about toxic and hazardous chemicals.Biological Technician Executed all functions required to produce parenteral viral vaccines in an aseptic environment. Utilized automated and manual cell culture systems in compliance with company and government regulations. Engaged in the manufacturing of injectable bacterial vaccines following a standard protocol.