Pfizer Mgr/TL Business Systems Validation in Kalamazoo, Michigan
This position is for the Mgr/TL Business Systems Validation. The successful candidate will Lead the Business Systems Validation team to ensure that defined quality standards and objectives are met. This position acts to ensure oversight over, and ownership of all Quality Business Systems at the Kalamazoo site. The role provides input for the development of site strategies, in order to ensure compliance with global and regulatory expectations.
Ensures cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes. Fosters teamwork and colleague development, as well as change management, within the department and the function.
Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values, norms, and behaviors. Provides oversight to individuals and team on personal development, performance, and quality related issues. Writes and delivers performance reviews and performs second level reviews as required. Provides oversight of department, ensuring proper use of assets, budget, and personnel.
QO Technical Knowledge (understand GMP compliance, Kalamazoo product/process knowledge)
Quality Systems Knowledge (understand related quality and compliance systems including deviations, change management, validation, documentation, etc.)
Manage Colleagues (performance reviews, development discussions, build teams, foster colleague engagement, deliver results, manage through others, etc.)
Operation Knowledge Preferred (Pharmaceutical Computer Quality Systems experience)
Oversight of the Business System Validation (BSV) Group
Understand regulatory requirements and audit strategy
Provide support for the BSV Group during inspections
Review and approve cGMP Documentation to assure compliance with regulatory requirements
Review and approve cGMP Changes
Review and approve training to assure cGMP requirements are met
Manage Resources to meet organizational goals
Understand site financial systems
Understand Safety concerns and maintain safe environment (5S, ergonomics)
Ability to perform GAP assessments for new & revised PQS
Ensure participation in company-wide knowledge exchanges
Ability to drive change as required by the organization
Education - Minimum BS/BA in science or computer science related discipline
Experience - Minimum of 10 years Computer Systems experience in a cGMP environment including experience with electronic change control systems
Excellent written and oral communication skills with the ability to interact with senior leadership and diverse global teams
Strong analytical and problem solving abilities
Excellent organizational skills, ability to handle changing deadlines and responsibilities
Demonstrated ability to pay close attention to detail and accuracy
Ability to work both independently and in a team environment
Ability to manage change and deal with ambiguity
Demonstrated ability to build strong relationships with both peers and customers
Knowledge of Kalamazoo Site Business Systems
Database querying knowledge
Ability to understand/interpret customer requirements, recommend/develop business solutions and ensure adherence to project timelines and budgets
Demonstrated Project and or People Management skills
Knowledge of GMP requirements for computerized systems and standard operating procedures
Ability to work at a computer for long hours is required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Little to no travel expected
Occasional off hours support of computerized systems may be required
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.
Last Date to Apply: January 24, 2019
Eligible for Relocation Package
Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.