Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. What You Will Achieve
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. In your role, you will join a team which is primarily responsible for the establishment and execution of the validation strategy for Facility, Utility & Equipment validation to ensure that the validation documentation is compliant with plant and corporate validation requirements and policies. This role is also responsible for a give technical services & continuous improvement projects. More broadly, you will be joining a department which aims to foster a culture of compliance and continuous improvement amongst all personnel who operate within the Validation team.
As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your expertise will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It Manage multiple projects / ongoing work activities within the department typically involving cross-functional representatives. Lead a team of full time and contract validation engineers to provide guidance on planning and execution of validation activities. Provide required technical & tactical guidance to the reporting team, completing performance management actions and regular 1:1s. This role is accountable for activities involved in the evaluation, review and approval of validation project plans, validation protocols and reports, and other validation lifecycle documentation. Develop and evaluate quality process and system standards to ensure compliance with company standards and governmental regulatory requirements. Investigate & troubleshoot validation problems for equipment and/or performance processes, conducting statistical analyses of testing results and process anomalies. Write, review, approve and/or implement documentation for new and current validation procedures and technical reports related to equipment, products and/or processes. Plans and oversees the execution of validation, technical services and improvement projects activities following applicable regulatory and Pfizer guidance. Ensure applicable VMPs and documents are maintained to GxP compliance. Implements department strategy, by leading cross functional projects in the design or redesign of projects. Ensure that appropriate systems are in place such that site operations meet or exceed the requirements . Provide lea dership to site technical staff regarding the development of validation strategies and validation master plans for equipment, computer system, process, cleaning, facilities, utilities and manufacturing equipment. Present validation packages to boards of health/regulators & internal inspections. Allocate department staffing and manage the utilization of facilities and equipment to ensure that department and site objectives are met within budget guidelines. Establish governance and contributor accountability for timely project completion. Develop, introduce and review practices and cultural changes that enable the department to meet business demands within agreed timeframes and expected regulatory standards. Qualifications Must-Have Bachelor's degree with 5+ years of relevant validation or quality experience within the pharmaceutical industry; OR a Master's degree with 3+ years of relevant validation or quality experience within the pharmaceutical industry; OR a Ph.D. with 0-2 years of experience; OR an Associate degree with 8+ years of relevant validation or quality experience within the pharmaceutical industry; OR High School Diploma (or Equivalent) with 10+ years of relevant validation or quality experience within the pharmaceutical industry People Management experience Excellent written and verbal communication skills with the ability to interact with senior leadership and regulatory agencies Good organizational, presentation, meeting facilitation, project/time management and technical writing skills Strong Analytical and problem-solving abilities Nice-to-Have Previous tech transfer experience. Extensive understanding and knowledge of regulatory requirements and validation as applied to the pharmaceutical equipment and facilities B ackground in problem solving, negotiations, data integrity principles and project management/support in a matrixed reporting environment Prior experience in other areas of validation (including equipment or aseptic or process validation) Good understanding of risk management methodologies, with a proven ability to apply to p harmaceutical operations Physical/Mental Requirements Requires routine sitting, standing, walking, listening and talking Acute mental and visual attention at all times Handle multiple projects while managing frequent interruptions Requires moderate lifting or moving up to 25 pounds Non-Standard Work Schedule, Travel, or Environment Requirements Must be capable of supporting up to 10% travel (domestic and international) Must have the ability to work effectively under strict deadlines The McPherson Site is a 24/7 operation. Must be able and willing to work outside of typical business hours to support the business, which may include weekends and holidays Other Job Details Last day to apply: March 19, 2024 Relocation support available Work Location Assignment:On Premise
The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Quality Assurance and Control
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