ROLE SUMMARY Reporting to the Validation Manager, the Validation Section Manager is responsible to organize and coordinate activities for new projects to ensure that the validation\u00a0practices are compliant with all of the most current applicable regulatory requirements and are current with industry standard. In addition, they are responsible for prioritizing, tracking, and reporting of major validation initiatives, including resources (both physical and personnel) and capital validation budget. The Section Manager will be required\u00a0to organize and coordinate activities and to provide strategic guidance\u00a0to the team to build a sustainable project management model moving forward. The ideal candidate will be an excellent leader and will have some level of pharmaceutical validation (or regulated industry) experience in managing staff of different disciplines to produce results in a timely manner. They\u00a0will also be able to develop efficient strategies and tactics. ROLE RESPONSIBILITIES Formulate, organize and monitor\u00a0inter-connected projects. Decide on suitable\u00a0strategies and objectives. Coordinate cross-project activities. Lead and evaluate\u00a0project managers, contingent workers\u00a0and other staff. Apply change, risk and resource management. Reporting the status of validation activities to fulfill regulatory requirements, and keeping abreast of changing regulatory requirements, government audit policies and the availability of current techniques. Assists in the presentation of validation documentation to regulatory and third party representatives during inspections and audits. Reviews and approves the validation sections of the NDA\u2019s and AND\u2019s. Supervise 4-5 exempt FTE and contractor support. Writes Validation Master Plans and remediation plans as needed. Makes sure all activities are completed on time to ensure systems and processes remain in a controlled\/validated state. QUALIFICATIONS Incumbent must have a minimum of seven (7) years of experience with a pharmaceutical GMP environment in one or more of the following disciplines: Validation, Process\/Product Engineering or Quality Assurance.\u00a0 The position requires a Bachelors\u2019 Degree in Engineering or Science.\u00a0 Candidates with other technical Bachelor\u2019s degrees will be considered if they have five (5) or more years of direct validation experience.\u00a0 Must have a minimum of five (5) years of direct validation experience.\u00a0 Must have thorough knowledge and understanding of cGMPs, FDA and EU regulations and current pharmaceutical industry standards.\u00a0 Must have extensive experience talking\/dealing with regulatory and third party representatives.\u00a0 Must have good organizational, presentation, meeting facilitation, project\/time management and technical writing skills. A minimum of three (3) years of supervisory experience is required with supervision of exempts being preferred. In place of the three-year supervisory experience, experience in project management\/leadership may be considered. PHYSICAL\/MENTAL REQUIREMENTS Responsible for the review of the integrity of validation reports which includes analyzing and interpreting data and results. Must be able to make and defend decisions on acceptability of qualification and validation activities based on document acceptance criteria, regulatory guidance, and company policy. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Position is 1st shift Mon-FRI with adjustments as necessary to support operations.\u00a0 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. 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\u2019s 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. Last Date to Apply for Job: February 15, 2018 Eligible for Relocation Package Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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