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.
Right now, we are seeking highly qualified candidates to fill the position:
The Medical Quality & Compliance Manager (MQCM) role drives quality management, compliance, inspection readiness, training, process improvements, and oversight needed to ensure high quality performance of Pfizer Baltics (Estonia, Latvia, Lithuania and Belarus) Medical Operations.
- Drive the local Country Quality Management System Lead the development of country quality & compliance strategic initiatives based on risk and business needs, in close collaboration with Local Medical Management and other stakeholders
- Development and maintenance of Country Quality Plan
Audits & Inspections:
- Lead continuous inspection readiness efforts in collaboration with applicable headquarters inspections management teams, Business Units, and Platform Line representatives
- Communicate relevant Inspection / audit trends to respective country stakeholders, drive that applicable actions are taken to address country gaps
- Develop and maintain the in-country Regulatory Inspection Action Plan. Lead, coordinate or support local regulatory authority inspections as per Pfizer standards Support maintenance of professional records for Medical colleagues
SOPs & Other responsibilities:
Develop (and/or support the development), implement and maintain in-country controlled documents Facilitate local implementation of global SOPs and ensure relevant communication is cascaded accordingly
- Upon identification of risk or potential quality issue, escalate to management as per Pfizer standards
- Drive effective management of quality issues and Corrective & Preventive Actions (CAPAs).Ensure training requirements related to Medical and Compliance processes are included in the appropriate curricula
- Ensure local curricula are maintained in line with Pfizer standards Conduct quality reviews and report on results or defined quality analytics to in-country Medical Management and other stakeholders;
- Scientific or technical degree is preferred: BSc and over 3 years' experience in compliance/SOP management, auditing, QA/QC or related field
- Previous experience in a role involved in the drug development process is valued * Supervisory experience in a matrixed organization is valued
- Knowledge of training design and tools and experience in applying training methodology is considered a plus
- Continuous Improvement and/ or organizational effectiveness expertise * Project Management expertise
- Expertise in managing multiple complex projects
- Consultancy skills
- Fluency in English
We offer to the successful applicant opportunities to work in an International dynamic and very stimulating environment, professional growth and very good remuneratioon and social benefits package.
To apply please visit Apply link or www.pfizercareers.com and search for JobID: 1049034.