Manager QA Compliance T/L
Manager QA Compliance T/L
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$ 102900 - 171500
1 Vacancy
Job Description
Use Your Power for Purpose
Every day everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture which is both science and risk-based is flexible innovative and customer-oriented. Whether you are engaged in development maintenance compliance or analysis through research programs your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards making a real difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work.
What You Will Achieve
In this role you will:
Oversee and maintain the Regulatory Internal Audits Inspection Readiness and Site Training Quality Systems for the site including management of any network projects which impact the site. Ensure the Quality Systems comply with cGMP standards and corporate quality standards. Partner with site management team to effectively design develop and implement programs to support business goals and site strategies.
- Manage a team of Quality professionals providing support to Operations Engineering Laboratory and Validation in subjects such as Regulatory Internal Audits Inspection Readiness and Site Training.
- Oversee hiring training and professional development of employees.
- Serve as the primary point of contact for systems under responsibility.
- Oversee and maintain the Training Quality System as the Personnel & Training Management LPO for the site.
- Ensure the Training Quality System complies with cGMP standards and corporate quality standards and ensure that all colleagues and contingent workers are qualified to perform their GMP responsibilities.
- Provide support through regulatory inspections readiness and processes (e.g. FDA PMDA ANVISA EMA).
- Ensure the site Quality Processes and Systems are robust effective consistent and compliant with regulatory requirements through internal audits.
- Provide data and support to the Quality Review Board to meet Corporate initiatives and ensure compliance with procedures.
- Establish and monitor metrics and drive continuous improvement of quality system.
- Expand cross-functional organizational capacity by collaborating across departments on priorities functions and common goals.
Here Is What You Need (Minimum Requirements)
- Applicant must have a bachelors degree with at least 4 years of
experience; OR a masters degree with at least 2 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 - Knowledge of national and international GMP regulations/guidance relevant to the production and control of pharmaceutical/biopharmaceutical industry
- Experience in auditing with Good Manufacturing Practices (cGMP) regulated industries
- Experience utilizing Learning Management Systems at a production site
- A successful track record of continuous improvement and the development/implementation of best practices in Quality Operations or manufacturing
- A team player with strong interpersonal organizational and communications skills are a must. Additionally the candidate must be self-motivated engaged and able to perform moderately complex tasks independently with flexibility to changing priorities
- Demonstrated management experience either through direct people leadership or significant project management experience
- Fluency in English both speaking and writing
PHYSICAL/MENTAL REQUIREMENTS
This position will spend significant time in an office environment however may be required to work in a production warehouse or laboratory environment as appropriate and must be able to wear all required PPE including aseptic gowning.
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
- May require support for site as needed beyond core business hours.
- Little to no travel 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 E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing please email. This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and/or interviewing. Requests for any other reason will not be returned.
Required Experience:
Manager
Employment Type
Full-Time
