25 days old

Biological Quality Manager

Pfizer
McPherson, KS 67460
**ROLE SUMMARY**

The Biological Quality Manager leads the supervisors responsible for Microbiological/Endotoxin testing at all stages of the product lifecycle (i.e. incoming, in-process, final release and stability). The Manager is also responsible for colleagues that perform the quality review, trending and reporting of the laboratory testing and completion of any investigations associated with the testing or data.



Responsibilities include quality control in process and batch release data management in conformance of Data Integrity principles, nonconformance reporting, analytical related OOT and OOS investigations, corrective and preventive actions, GMP document changes, change control and performance metrics.



The colleague will have working knowledge and experience with the applicable compendia (to include USP and EP). Assure quality systems are in place meeting cGLP/cGMP compliance of departmental, company and regulatory objectives as well as 21CFR compliance for data. Will be required to interface with regulatory inspectors and other auditors.



Performs budget feedback, HR hiring/staff functions and performance/merit reviews. Oversight of the supervisory staff including support of all departmental functions/objectives as well as colleague development and growth.



**ROLE RESPONSIBILITIES**



+ Manage a large and diverse team of Supervisors, Quality Microbiologists and technical professionals to achieve quality, compliance and business objectives regarding all aspects of Microbiological Quality Control.

+ Responsible for Analytical Disposition of cGMP raw materials, components, applicable GMP consumables, bulks and finished goods according to approved test methods in accordance with Data Integrity Principles. Role has financial impact totaling value of all products manufactured at the McPherson Site.

+ Analyze, develop and improve quality systems and associated business processes to achieve compliance with local, corporate, and global regulatory requirements.

+ Develop and maintain policies, standards, procedures and guidelines encompassing all analytical quality systems and, facilitate deployment.

+ Required to have working knowledge of site procedures, corporate guidance and regulatory expectations pertaining to laboratory testing and practices.

+ Support investigation activities utilizing root-cause and problem-solving methodologies as well as support CAPA development and implementation.

+ Maintains the projects pertaining to CAPAs and continuous improvements for the Microbiological/Endotoxin laboratories.

+ Develop and maintain department and site metrics for monitoring critical process and Quality attributes against compelling business needs.

+ Required to coach, mentor and develop colleagues for future roles at the site.

+ Review and approve technical documentation in support of cross-functional initiatives.



**BASIC QUALIFICATIONS**



+ Bachelor's Degree in Microbiology, Biology or related science required.

+ 5+ years of Quality or Regulatory or Operations experience in a cGMP regulated industry required.

+ 3+ years of experience in a management/leadership role with direct reports in quality and or compliance required.

+ 2+ years of experience in a QC Microbiology laboratory in a cGMP regulated environment required.

+ CAPA and root cause expertise required.

+ Thorough knowledge of GMPs and their application in quality control is required.

+ Experience in interfacing with regulatory agencies and regulatory site inspections is essential.

+ Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.

+ Requires strong interpersonal skills and the ability to handle multiple projects

+ Ability to make decisions utilizing experience along with site processes and procedures.



**PREFERRED QUALIFICATIONS**



+ Experience within the pharmaceutical or biotech industry is preferred.

+ Project management experience preferred.

+ Experience with six sigma methodology preferred.



**PHYSICAL/MENTAL REQUIREMENTS**



+ Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations or data analysis.

+ Ability to multi-task and work in a fast-paced environment.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



+ This position may require some weekend and off shift as business needs dictate. Successful candidate will spend up to 50% of their time in a microbiology laboratory.

+ Some infrequent travel.



**Other Job Details:**



+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus



\#LI-PFE



**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.



Continuous Imprv and Proj Mgmt



\#LI-PFE

Categories

Posted: 2021-02-04 Expires: 2021-03-21

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Biological Quality Manager

Pfizer
McPherson, KS 67460

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