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
The Supplier Quality (SQ) Manager provides leadership to the Supplier Quality Investigations (SQI) team to ensure Pfizer supplier quality programs are implemented and sustainable. They evaluate and control the activities of the SQI team to assure its work is accurate, timely, efficient, and compliant with company policies, industry standards, and government regulations.
Additionally, the SQ Manager is responsible for the management and compliance of the Rocky Mount SQI program, including global and site driven initiatives, supplier change notifications, supplier qualification, and supplier audit programs. They also represent the SQ program in regulatory inspections and third-party audits.
The SQ Manager interacts with multiple Quality functions across the site, including chemical, biological, and manufacturing quality groups, in addition to manufacturing leadership and process personnel and proactively partners with site and global Supply Chain, Operations, and Quality colleagues in supporting suppliers.
How You Will Achieve It
- Provide leadership for Supplier Quality Investigations team
- Lead the Supplier Quality Investigations program, including:
- Supplier Qualification
- Maintenance of the Supplier Management System (SMS)
- Supplier Auditing and adherence to Audit Schedule
- Supplier Change Notification process
- Liaising with the Suppliers
- Evaluating and responding to Supplier Alerts
- Change Requests related to Supplier Quality
- Vendor Reassessments
- Supplier Metrics
- Quality Agreements
- Establish/maintain relationships with multiple departments/stakeholders
- Establish and maintain collaborative relationships with Pfizer Global Supply groups (center functions, other sites)
- Assure all relevant systems, processes, and their outcomes comply with standards that meet applicable international and national regulations and guidelines
- Provides Subject Matter expertise on Supplier Quality/Compliance related matters
- Review, evaluate, and support assessments, audits, and investigations, including writing formal investigative reports
- Escalate and present formal notification of significant issues to appropriate management
- Lead Process Improvements using continuous improvement too l s
- Supplier Qualification
Qualifications
BASIC QUALIFICATIONS
- Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
- Experience in Quality Management Systems Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
- Proactive approach and strong critical thinking skills Flexible to work in a team environment within own team and interdepartmental teams
- Excellent communication and interpersonal skills
- Thorough knowledge and understanding of pharmaceutical regulations and guidelines, including but not limited to cGMPs, GLPs, ICH, USP, FDA and other applicable industry guidelines.
- Widespread knowledge of manufacturing-facility components .
- Familiarity with the non-conformity and resolution process.
- Experience as a leader of direct reports for at least two years, with leadership of people leaders being beneficial or indirect leadership experience with proven success
- Demonstrated ability to work/contribute in a team-based environment as a lead and a participant, with exceptional interpersonal skills.
- Effective communication skills, both written and verbal, and a proven ability in technical writing.
- Strong organizational, presentation, meeting facilitation, analytical, and problem-solving skills.
Nice-to-Have
- ASQ/CQA Certified Quality Auditor or ASQ/CQA-Certified Quality Engineer
Strong computer proficiency skills in MS Office, Word, Excel, Access, Project, Learning Management Systems, document tracking systems, Trackwise or equivalent.
PHYSICAL/MENTAL REQUIREMENTS
- Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
- Require working in an office setting where sitting and computer usage would be the norm
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Non-Standard Work Schedule, Travel, or Environment Requirements: This role is standard day Monday through Friday work shift; some off-shift support needed when issues arise
Limited travel for the position; no more than 5% traveling.
\nRelocation support available\n
Work Location Assignment: On Premise
The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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 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. This position requires permanent work authorization in the United States.
Quality Assurance and Control
#LI-PFE