Senior Manager, Investigations and CAPA

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.

Reporting to the Director Manufacturing Quality and Investigations, this position serves as the site champion for investigation and CAPA, supporting all functional operations and products at the McPherson facility.

This role manages a team of 20-30 Quality professionals and people leaders and is actively engaged in strengthening the site investigation culture through leading, coordinating, planning, assessing, and reporting investigation effectiveness in line with regulatory standards as well as company policies and best practices. Promotes consistency in investigation practices across the plant. Reviews and evaluate sensitive, confidential information and develop recommendations for use by plant Quality management.

This role is instrumental in developing and leading the overall site investigations strategy for reducing repeat manufacturing and safety investigations/incidents, influencing site leadership, and enhancing a Quality and EHS culture that drives zero defects.

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

• Own and ensure a robust investigations process for the site through the consistent and effective use of investigation processes and create an investigation culture across the site.
• Actively lead and participate in lean activities to drive continuous improvement.
• Actively perform routine assessments of the site investigation system and discuss opportunities with management. Work to develop strategy and action plans for improving the system where opportunities are identified.
• Ensure robust and sufficient training and coaching resources for DMAIC model are available and occur in a timely manner to meet site investigation goals.
• Participate and regularly contribute to global discussion groups and with user council representatives for system improvements. Collaborate (as needed) with the site PHP lead on human performance measures.
• Manage diverse team of Colleagues (performance reviews, development discussions, build teams, foster colleague engagement, deliver results, manage through others, etc.)
• Understand site safety objectives and maintain safe working environment (5S, ergonomics)

• Bachelor's Degree
• 7+ years' experience.
• Strong people management experience
• Related experience in GMP-regulated industries in Manufacturing Operations, Process Validation with Quality Systems knowledge
• A minimum 5 years in a management or leadership role in quality assurance, change management, and/or compliance leading a team of at least 10 individuals.
• Capable of interfacing with multiple levels of people within the organization including corporate management, third party customers, and plant personnel.
• Demonstrated record of successful interaction with global regulatory and other internal and external auditing groups
• Thorough knowledge and understanding of the technical and commercial aspects of pharmaceutical API products, Current Good Manufacturing Practices {part of GxP}, validation principles, and applicable regulations
• Excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups

• Some experience in all types of investigations (manufacturing, laboratory, and complaint)
• Strong analytical and problem-solving abilities including six sigma methodologies. Decision-making based on a risk science based approached.
• Previous experience in Quality Risk Management
• ASQ Certified Quality Engineer and Six Sigma Green Belt
• Experience using data analysis computer tools and statistical analysis is preferred.
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PHYSICAL/MENTAL REQUIREMENTS

• Individual will be required to perform task of walking the process and understanding the areas in which the incidents occurred which may require periods of standing.
• Individual will be required to generate investigational reports within the enterprise system which will require periods sitting/typing

• Individual will be required to organize and prioritize in a dynamic operation
• Individual will be required to perform complex data analysis

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Position may require non-standard work schedule to conduct interviews with individuals involved in the investigation and/or to complete investigations per required timeline.
• Ability to work in a flexible workspace between on site and remote working environments
• Limited travel

Last Date to apply: 9/30/22

Relocation support available

Relocation assistance may be available based on business needs and/or eligibility.

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.