drjobs QA Manager Compliance (Secondment - 6 Months)

QA Manager Compliance (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

Why Patients Need You

Every day Pfizers unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and riskbased compliance quality culture is both flexible and innovative always putting the patient first. Whether you are involved in development maintenance compliance or research analysis your contribution directly impacts patients.

What You Will Achieve

The Manager of Quality Assurance (Digital Application) is responsible for leading the Operationalizing Quality program at the PGS Sanford site. Operationalizing Quality is an initiative designed to align qualityrelated activities to meet Key Performance Indicators (KPIs) through realtime metric reporting and datadriven decision making as well as

The Manager of Quality Assurance (Digital Application) role is highly strategic and will leverage digital technologies to develop sustainable solutions to ensure quality related activities (Change Control Investigation Batch Release Quality Control and Supplier Quality) meet site defined KPIs and business needs.

The Manager of Quality Assurance (Digital Application) works with site Quality Operations leaders and collaborates with other functions such as Operations Tech Ops Supply Chain and Global Technology amongst others to align develop and support the implementation of effective digital tools and an effective Inspection Readiness program.

The Manager of Quality Assurance (Digital Application) reports to the site Compliance Director.

How You Will Achieve It

  • Develop and deploy contemporized digital tools for reporting on Quality activities as they relate to Business and Compliance needs

  • Understand requirements of the Quality System

  • Work with sponsors stakeholders and governance to ensure alignment of contemporized processes

  • Manage effective end user training planning and solution delivery

  • Execute timely on deployment phase deliverables

  • Support inspections (Pre/During/Post)

  • Apply digital solutions to guide organization in incorporating changes to their business process identify / anticipate change impact and articulate to leaders integrate horizontally and vertically.

Qualifications

MustHave

Applicant must have a bachelors degree with at least 5 years ofexperience; 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 yearsof experience; OR a high school diploma (or equivalent) and 10 years ofrelevant experience.

  • Ability to lead and drive projects/initiatives to completion

  • Strong oral and written communication skills

  • Able to work and contribute effectively in crossfunctional team culture differences diversity.

  • Experience with conducting gap assessment and system and process risk assessments.

  • Familiar with quality auditing.

  • Demonstrated business acumen experience in managing projects teams programs or workstreams of varying levels of complexity

  • Demonstrated cGMP experience with compliance issues

  • Proactive approach and strong critical thinking skills

  • Project Manager team leader/project leader or coach

  • Strong verbal and written English communications capabilities

NicetoHave

  • Masters degree

  • Demonstrated previous experience in problem solving decision making negotiating and conflict resolution skills

  • Capability in Lean tools and/or desire to grow Lean capabilities to further drive Continuous Improvement projects.

  • Functional knowledge of Microsoft SharePoint and Office applications particularly Excel

PHYSICAL/MENTAL REQUIREMENTS

Must be able to stand or walk for an extended period of time.

NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Minimal travel

Role will require after hour and weekend support from time to time.

Work Location Assignment:On Premise

Other Job Details

  • Last Date to Apply for Job:June 3 2025

  • Additional Location Information:NO

  • 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.

  • There will be no change to your current work location.

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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