Manager QA ADC
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Job Location:
Pearl River, NY - USA
Monthly Salary:
$ 99200 - 160500
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
Use Your Power for Purpose
Every day our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible innovative and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development maintenance compliance or analysis through research programs your contribution directly impacts patients.
What You Will Achieve
In this role you will:
Provide QA support to Manufacturing and Laboratories
Focus on Quality Systems including site Change Management
Accountable for the overall management of the site Change Management process; acts as gate-keeper of the change by authorizing/approving the change from plan approval through implementation and closure
Assess all changes for Regulatory impact by reviewing dossier content and collaborating with GCMC Regulatory Strategists as needed
Initiate PCFs in PDM for regulatory impacted changes
Author/approve Annual Product Review reports for commercial products
Perform Informa linear regression analysis for stability trending for commercial products to meet ICH guidelines
Support submission activities including authoring of stability content and review of CTD content; approves Forms 456 and 459.
Create/approve stability protocols and product complaint investigations for commercial products.
Acts as SME and Audit Escort/Host for BOH inspections
Lead and guide moderately complex projects managing time and resources effectively and apply skills and discipline knowledge to departmental work
Make decisions to resolve moderately complex problems develop new options guided by policies and operate independently in ambiguous situations
Utilize judgment and experience to potentially become a resource for others and evaluate clinical and commercial drug batches to ensure adherence to specifications
Identify deviations in manufacturing and packaging processes approve investigations and change control activities and guide operational teams in project management
Prepare forecasts for resource requirements identify areas for improvement and facilitate agreements between different teams using leadership skills
Assess supplier operations for regulatory compliance conduct quality reviews and report results to relevant medical and quality groups
Support the development of country quality strategic initiatives lead continuous inspection readiness and drive effective management of quality issues and CAPAs
Participate in internal cGMP audits support regulatory inspections perform disposition of clinical trial materials and communicate with internal and external customers to resolve project-related issues
Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues
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
Substantial experience in pharmaceutical manufacturing and quality control
Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects
Knowledge of regulations related to vendor management programs and other industry quality systems
Strong critical thinking skills and a proactive approach
Ability to collaborate effectively manage relationships and communicate well both in writing and verbally
Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM Quality Tracking System Trackwise and Documentum platforms
Bonus Points If You Have (Preferred Requirements)
Experience in Quality Systems in pharmaceutical medical device or combination product industry
Knowledge or exposure to data science
Strong leadership and team management skills
Ability to work under pressure and meet tight deadlines
Ability to influence and negotiate with stakeholders
Experience in conducting internal audits and supporting regulatory inspections
Experience using common AI tools including generative technologies such as ChatGPT or Microsoft Copilot to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices includingrisk management and ethical use.
PHYSICAL/MENTAL REQUIREMENTS
Ability to work in an office job involving use of a computer and to lead cross functional teams.
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability to support internal and external audit schedules during extended workday shifts.
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
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
About Company
Erfahren Sie mehr über uns als forschendes und produzierendes Pharmaunternehmen: Von unserem Beitrag zum medizinischen Fortschritt bis zur nachhaltigen Produktion.
