Sr Mgr Quality Assurance

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POSITION SUMMARY

This position is responsible for overseeing operational aspects of the Quality Assurance Department related to the Investigations for Operations and Laboratories; CAPAs, Effectiveness Checks, Protocols and Reports from but not limited to: Analytical Method, Equipment Qualifications, Process Validations. Also, manages Change Control System, LIMS/MES/SAP changes, Electronic Document Management System for the procedures, forms and any documentation supporting the sites in strict accordance with all Standard Operating Procedures, Current Good Manufacturing Practices, Company policies and procedures, and Food and Drug Administration requirements governing the manufacture of pharmaceutical products. Responsible for monitoring and overseeing trends in key areas and indicator from production and laboratories for implementation of corrective and preventive measures. This role requires close collaboration with cross-functional teams to ensure a seamless and successful achievement of Key Performance targets.

ESSENTIAL AREAS OF RESPONSIBILITY

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments. Manages Quality Operations – Quality Systems team activities for EDMS, Investigations, CAPAs, Effectiveness Checks, Protocols, Reports for Equipment Qualifications, Process and Method Validations and the Change Controls associated. Work closely with QC and Production for LIMS, MES, SAP changes. Work closely with Project Managers, R&D, Regulatory Affairs, Quality Control, Quality, Operations and Supply Chain teams for documents review and approval in a coordinated effort, and alignment on site priorities and launch objectives to ensure a seamless and successful KPIs. Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions. Responsible for completing all training requirements and maintaining 100% compliance with all assignments. Reviews and approves production and process control Standard Operating Procedures (SOPs) that are drafted, reviewed and approved by other organizational units. Support the identification, investigation, closeout of deviations and Corrective Actions & Preventive Actions. Coordinates with Operations to ensure compliance with and understanding of CGMPs, Company policies and practices, and safety procedures. Support inspections and audits to ensure compliance with CGMPs, SOPs, Company practices and procedures and governmental regulations. Prepare the monthly and quarterly Quality Council report for Deviations, CAPAs, CC, and any other Quality System required. Prepares reports for the Director of Quality and executive management. Provides support, in the areas of disciplinary action, problem resolution and planning. Ensures project deadlines and performance standards are established and met. Responsible for performing additional related duties as assigned. Your experience and qualifications Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. Education/Certification/Experience: Requires Bachelor Degree in Science, Engineering, Master Degree preferred from an accredited college or university, with a minimum of 8 years relevant progressive experience in the pharmaceutical industry, including 5 years in supervisor or managerial capacity. Preferably in a pharmaceutical manufacturing environment or related field. Skills/Knowledge/Abilities: Strong Project Management and organizational skills. Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and or/techniques for resolutions. Strong Root Cause Analysis knowledge/techniques on: FMEA, Cause and Effect Diagrams, Fishbone, 5M, 5Why. Responding to technical inquiries from management, peers, and regulatory agencies. Communicating clearly and concisely, both, orally and in writing. Operating scientific and personal computers. Managing multiple projects, duties, and assignments. Interpreting and applying Federal, state, and local policies, procedures and regulations. Directing, coordinating assignments of the QA department personnel. Establishing and maintaining cooperative working relationships with others. Principles of quality assurance management, leadership, and training. Principles of safety, worker’s compensation, OSHA, and related principles and practices. Pharmaceutical principles, practices, and their application. FDA, SOP, cGMP and other pertinent regulatory compliance and requirements. Pertinent Federal and State laws related to personnel administration. Skill levels in MS Office including proficiency in Word, PowerPoint, Excel and SharePoint. Must be able to maintain the highest levels of confidentiality, integrity and discretion. Excellent verbal, written, and interpersonal skills required. Problem Solving: Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors. Seeks out all resources when selecting methods and techniques for obtaining results. Acts independently and proactively to recommend and administer methods and procedures for problem resolution. Able to identify solutions to general problems through collaboration and creativity.

PHYSICAL REQUIREMENTS

Frequent: Sitting for extended periods of time at work station or mobile equipment. Using fingers to perform activities such as picking, pinching or typing. Walk Operations areas frequently. Visual Acuity Close visual acuity to perform activities such as computer work, preparing and analyzing data, extensive reading, and visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.

WORKING ENVIRONMENT

Exposure to low to moderate noise levels. Fast paced environment. Able to manage multiple priorities and ensure appropriate follow-ups. Highly organized and excellent time and project management skills with the ability to juggle a wide range. Ability to work under pressure and meet deadlines. How We’ll Take Care of You We offer a competitive benefits package, including: Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls. Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan. Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays. Life and Disability Protection: Company paid Life and Disability insurance. Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more. Already Working @TEVA? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, #J-18808-Ljbffr Tevapharm