Senior QA Compliance and Auditing Specialist I

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.

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your problem solving skills that will make Pfizer ready to achieve new milestones and help patients across the globe.

• Execute Internal and External Audits, to ensure Site’s compliance with current BOH expectations. This includes sound audit preparation, execution, timely reporting and follow up on actionable items.
• Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the Department.
• Provide oversight to the suppliers by access the need to perform audits.
• Support the development of Site Compliance strategic initiatives based on risk and business needs, in close collaboration with key stakeholders.
• Participate in continuous inspection readiness for the Site.
• Networking and sharing of best practices with Corporate Compliance colleagues and with other compliance functions in other Pfizer affiliates.
• Ensure the Site is executing in compliance with Good Manufacturing Practices {also cGMP} by performing audits and supporting regulatory inspections or corporate audit activities.
• Communicate with and influence internal and external customers across site and department boundaries to ensure compliant and aligned resolution of project related issues and investigations.
• Responsible to develop and adhere to Site Internal and External audit schedule to meet procedural requirements.
• Contribute to the maintenance of the Site Audit program in compliance with the applicable PQS’, as well a continuous improvement of the program.
• Ensure ongoing presence within the Quality Control, Manufacturing and Engineering Areas to assist the Site’s ability to maintain an exemplary compliance.
• Establish him/herself as Site SME for cGMP related compliance, and be a resource to the functions as needed.

Role Summary

The Senior QA Compliance Specialist is a senior contributor to the Compliance and Auditing team with responsibility to support the Site’s ability to maintain current with BOH (board of health) regulations and expectations. The incumbent is responsible for coordination and execution of the internal and external audits per applicable Site procedures and may lead cross site efforts/projects in support of compliance for the Site. Additionally, the Senior Specialist will support the Quality Agreements program for Service providers, with responsibility to establish Quality Agreements and maintain per site procedures. The Senior QA Compliance Specialist applies sound technical and quality knowledge to interpret and apply regulations/requirements across a broad range of cGMP activities on Site and in such, provides sound guidance/direction to the functions. The Senior QA Compliance Specialist makes complex and routine decisions with minimal guidance from management.

• Bachelor's Degree
• 5+ years' experience
• Pharmaceutical manufacturing/Quality experience
• Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects, regulations as related to vendor management programs and other industry quality systems and processes
• Proactive approach and strong critical thinking skills
• Strong collaboration, relationship management, and interpersonal skills
• Excellent written and verbal communication
• Advanced computer skills in MS Office applications and good knowledge of enterprise systems, such as PDM, Quality Tracking System Trackwise, Documentum platforms

• Master's degree
• Experience in Quality Systems in pharmaceutical, medical device, or combination product industry

• ASQ Certificate

• Previous auditing experience

PHYSICAL/MENTAL REQUIREMENTS

Office job involving use of computer with cleanroom gowning requirements. In addition to the following requirements: Lifting, sitting, standing, walking and bending.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Additional support outside normal business hours may be required (e.g. in support of inspections or key projects)"

Relocation support available

Work Location Assignment:Hybrid

Last Date to Apply: August 19 2022

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.

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.