Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
As a critical member of the site’s dedicated and highly effective Quality Operations Team, the QA Manager, Operational Support Lead will have accountability for day-to-day operation of the QA operational support department. They interface with other departments on site to ensure appropriate levels of service are being provided to support all operational activities taking place at the site.
The manager leads in setting the strategic direction to ensure that the site has robust and efficient processes for the operational areas, to maintain and continuously improve compliance with the regulatory requirements of all markets to which the site supplies products.
The Manager is integral part the Site’s Quality culture, they are responsible for being the sites first line to determine next steps once any issue arises. The provide leadership to the quality operational support team, as well as other departments on the site. They coach and mentor others on the importance of maintaining a high level of quality and compliance. Achieve compliance and business results through Partnerships between Quality and Operations, other site functions, and third parties.
The manager is accountable for making timely quality decisions, utilizing a scientific, risk-based approach. They will provide clear and timely action plans for issue resolution with appropriate escalation, communication, and closure.
How You Will Achieve It
Collaborates with key internal and external partners to ensure the Site’s needs are met with corporate standards
Provides strategic direction of the Site’s processes as it related to compliance to quality standards.
Active contributor within cross-functional teams on site and the network, developing workable solutions for quality oversight; continuously review and improve processes, and programs
Subject Matter Expert for quality operational support
Management of quality support activities (line clearance, AQL, batch record review, final dispositions, supplier management, material qualification, QAA etc.)
Responsible for leading the site’s Material Review Board (MRB)
Responsible for ensuring sites adherence to quality related metrics, along with creation of suggestive metrics which will help the site have leading indicators on performance
Fosters a culture of continuous improvement
Reviews and approves investigations, change controls, commitments, and procedures as they relate to the site’s operations
Lead efforts to implement continuous improvement to help build a robust quality oversight program
Responsible for mentoring and coaching others within the site and/or network (as applicable) on quality/compliance best practices
Responsible for making decisions on complex quality and technical issues
Must have High School degree with 10 years of relevant experience; OR an Associate's degree with 8 years of experience; OR a Bachelor’s degree with at least 5 years of experience; OR a Master’s degree with more than 3 years of experience; OR a Ph.D. with 0-2 years of experience
Demonstrated management experience, either through direct people leadership or significant project management experience.
Knowledge of GMP regulations/guidances (21 CFR Parts 11, 210 &211; EC Annex 15; ICH 7) as they pertain to the pharmaceutical/biopharmaceutical industry.
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.
A broad understanding of Biopharmaceutical Sciences processes an
Proficiency with basic business analysis tools such as process mapping, decision flowcharting, DMAIC, etc.)
Excellent communication skills including technical writing and presentation development and delivery
Proficient in data integrity principles and management of electronic records
Coaching/development of others
Willingness to establish networks (in site, across OpU / network)
This position will spend significant time in an office type setting as well as attending cross functional meetings.
Position will also support on the floor activities such as AQL sampling, gowning, event troubleshooting, etc.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Other Job Details:
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.
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.
Quality Assurance and Control