Pfizer Remediation Director in McPherson, Kansas
A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Please note, there are multiple openings for this position. If you wish to be considered for all positions, you must apply to each separate job IDThe Remediation Director is focused on strengthening of site Quality systems through leading quality, manufacturing, engineering, and validation compliance remediation activities at the McPherson site pharmaceutical manufacturing facility per the defined Quality Plan. Activities may include development, coordination and execution of testing, change requests, protocols and document revisions as required to meet regulatory and cGMP requirements. Lead the development and execution of remediation activities for a respective area (i.e. Engineering, Validation, Operations, Quality, etc.)Manage project activities through provision of oversight and guidance.Provide oversight for execution of the remediation strategy.Preview/provide feedback and technical/scientific support on any project deliverable, i.e. remediation strategy, plan reports, etc. *Monitor and communicate progress to ensure commitment actions are completed according to the defined plan.
Direct up to five professionals in the execution of remediation activities for respective area (Engineering, Operations, Quality or Validation)Responsible for reporting progress on remediation activities to the Program Management Office for presentation to Regulatory Agencies and Pfizer senior management team.Facilitates resolution and appropriate escalation of competing priorities and risks with stakeholders to ensure project success.Engages, influences, and coordinates all functions needed to execute/implement projects.*Preview/provide feedback and technical/scientific support on any project deliverables, i.e. remediation strategy, plan reports, resource needs, etc. *Recommends sustainability plan for post-remediation activities.
BS in Business, Engineering or Technical related field required10 years' experience in pharmaceutical or similar regulated industry required; prior Engineering, Operations, Quality or Validation assignments preferred. Experience authoring, review, etc. of procedures or training materials requiredExperience leading project teams or staff requiredPHYSICAL/MENTAL REQUIREMENTSNo unique physical requirementsMental:-Remains organized & positive in ambiguous and fast-paced, rapidly changing situations-Ability to analyze data from detailed schedule and risk management tools-Interface effectively with multiple stakeholder groupsNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Limited travel required. Non-standard work hour support of global conference calls, 24/7 manufacturing, etc. required when needed, though not typical of weekly requirements.
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.
Remediation Director McPherson, Kansas 1050099-1852