drjobs Validation Manager (Secondment - 6 months)

Validation Manager (Secondment - 6 months)

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1 Vacancy
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Job Location drjobs

Sanford, NC - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Use Your Power for Purpose

At Pfizer everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture rooted in science and riskbased compliance is both flexible and innovative always putting the customer first. Whether your role involves development maintenance compliance or analysis through research programs your contributions will be instrumental in ensuring that our products meet the highest standards of quality and safety.

What You Will Achieve

In this role you will:

  • Lead or colead moderately complex projects managing time and resources effectively while providing guidance

  • Apply skills and discipline knowledge to contribute to departmental work and make decisions to resolve moderately complex problems

  • Operate independently in ambiguous situations determining objectives of assignments and seeking directional review when necessary

  • Review your own work and potentially mentor others exercising judgment and becoming a resource for colleagues

  • Establish and implement validation strategies for equipment computer systems process verification and cleaning ensuring compliance with corporate policies

  • Guide operational teams in project management resource forecasting and identifying areas for improvement in products processes or services

  • Facilitate agreements between teams to achieve project goals and coordinate validation/qualification work including plans strategies and risk assessments

  • Review and approve change controls ensuring validation impact assessments and appropriate testing to maintain validated states

  • Collaborate with Operations Quality Technical groups and other site/network groups to meet business and compliance requirements

  • Provide technical support participate in change control implementations deliver validation training and ensure compliance with company policies and government regulations

Here Is What You Need (Minimum Requirements)

  • Applicant must have a bachelors degree with at least 5 years of experience; OR a masters degree with at least 3 years of experience; OR a PhD with 0 years of experience; OR as associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.

  • Strong understanding of validation principles and practices

  • Experience with regulatory requirements and guidelines for validation

  • Proficiency in project management and resource planning

  • Ability to work independently and make decisions in ambiguous situations

  • Excellent communication and interpersonal skills

  • Proficiency in computerized systems and software applications

Bonus Points If You Have (Preferred Requirements)

  • Masters degree coupled with relevant pharmaceutical experience

  • Comprehensive knowledge of GMP regulations and guidance including 21 CFR Parts 11 210 & 211 EC Annex 15 and ICH 7

  • Strong background in problemsolving negotiations and data integrity principles

  • Experience in project management/support within a matrixed reporting environment

  • Good understanding of risk management methodologies and their application to Biopharmaceutical operations

Other Job Details

  • Last Date to Apply for Job:MAY 26 2025

  • Additional Location Information:N/A

  • Eligible for Relocation Package NO

  • Secondment 6 months

  • If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for12 months or longer you will be required to turn in your fleet vehicle for the duration of the nondriving secondment. Please refer to the Fleet Policy and Procedures document for more information.

  • This secondment offers a valuable opportunity for professional growth. It will need to be funded by the secondees home market.

PHYSICAL/MENTAL REQUIREMENTS

Position requirements are typical for an officebased work environment. There are no unusual physical or mental requirements for this position.

NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Schedule is primarily day shift but may require offshift work on occasions. The position may require working on the floor in manufacturing at times which will require a heightened safety awareness and aseptic gowning will be required.


Work Location Assignment:On Premise

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 providers 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 EVerify employer. This position requires permanent work authorization in the United States.

Quality Assurance and Control


Required Experience:

Manager

Employment Type

Full-Time

Company Industry

About Company

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