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Quality Compliance Manager

at Pfizer in Memphis, Tennessee, United States

Job Description

Why Patients Need You

Our manufacturing logistics and supply team makes sure that customers and patients have the medicines they need, when they need them. You’ll help bring medicines to the world even faster by embracing challenges, imagining what’s possible and taking action.

What You Will Achieve

Develop and implement quality systems for the Memphis Logistic Center. Evaluate current and proposed regulations, both domestically and internationally to ensure compliance of the supply chain for incoming and outgoing shipments. Manage the integration of new products and services to ensure compliance with all applicable regulations and standards. Manage the Quality Hold process and support the global recall systems. Manage the overall site metrics and ensure continuous improvement. Provide guidance and oversee the investigation and change control systems and ensure the operations team is owning the individual investigations and commitments. Quality review of all capital projects for the logistics network. Regulatory management of distribution site licensing for the distribution facilities, i.e. wholesale distribution licenses, manufacturing licenses (over labeling), controlled substance licenses and importation licenses.

How You Will Achieve It

+ Research, interpret, and act on current and proposed regulations (domestically and internationally) that impact supply chain operations.

+ Establish quality systems and procedures that minimize quality cost and provide a high level of compliance and customer satisfaction.

+ Develop operational procedures and training material as appropriate. Manage updates to all standard operating procedures and applicable PQSs and PMs, when needed or required.

+ Initiate, manage and facilitate quality system improvement projects.

+ Interface with other departments to manage/facilitate new product introductions. Develop the strategies and systems to position inventory to be first to market.

+ Develop and implement quality agreements with third party logistic providers.

+ Lead and direct the management review process for the supply chain organization.

+ Manage the quality improvement initiatives that are strategic to the business.

+ Perform validation and qualifications in accordance with corporate requirements.

+ Review all major Capital expenditures affecting systems and facilities. Evaluate the impact on cGMP’s, and other applicable regulations/standards.

+ Provide quality consultation to supply chain operations and support functions.

+ Monitor and track performance metrics and quality costs with a focus on preventive actions.

+ Manage the Corrective and Preventative programs and investigations related to supply chain.

+ Direct the activities of the compliance assessment program for supply chain.

+ Investigate complaints that may be associated with the supply chain organization and develop corrective actions.

+ Establish quality plans and strategies for supply chain operations.

+ Manage the quality hold system and support the recall systems and strategies.

+ Review and verify returned goods and coordinate destruction with returned goods supplier and FDA.

+ Assure compliance to FDA and global regulations to ensure effective quality holds and field actions.

+ Manage the SAP procedures and training for Site Quality colleagues.

Qualifications

EDUCATION REQUIREMENTS:

Bachelor’s Degree in Biology, Microbiology, Chemistry, Biochemistry, Pharmacy, Engineering or related science field, Supply Chain or Business required.

EXPERIENCE REQUIREMENTS:

Five to ten years combined experience in quality/supply chain operations in the health care sector. Knowledge of quality systems and regulations impacting drugs, medical devices and biologics. Strong written and verbal communication skills. Knowledge of compliance assessment/audit processes. Strong interpersonal skills as well as a strong general business aptitude and outstanding ethics. Ability to work through others at all levels in the organization with logical and persuasive style.

REQUIRED SKILLS:

+ Working knowledge of GMP and GDP regulations

+ Familiarity with USP requirements

+ Strong communication skills

+ Strong collaboration, partnership, and interpersonal skills

+ Quality/Compliance competency

+ Technical writing skills

Other Job Details:

+ Last Date to Apply for Job: October 28, 2021

+ Additional Location Information: Memphis, TN

\#LI-PFI

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Logistics & Supply Chain Mgmt

\#LI-PFE

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Job Posting: JC186965724

Posted On: Jul 02, 2021

Updated On: Oct 18, 2021