Manager, Quality & Inspection Readiness -1
- Employer
- Bristol Myers Squibb Company
- Location
- Princeton, NJ, United States
- Start date
- Jul 12, 2019
View more
- Discipline
- Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Audit Management
Develop and execute audit management training for subject matter experts
Coordinate pre-audit and inspection documents including streamlining information needed from global PV functions and the safety database
Liaise with Global Quality and Regulatory Compliance (GQRC), PV International Team and other key stakeholders
Conduct mock inspection interviews focused on subject matter expert role-based content as well as general inspection conduct
Improve and implement efficient methodologies and tools for the handling of internal audits
Maintain a department Corrective and Preventative Action (CAPA) system for findings/observations due to audits, inspections, and quality events, including developing reports for trend analysis
Maintain oversight, guide subject matter experts in developing solid CAPA, and facilitate resolution of CAPA from audits in order to prevent repeat or complex resolution to findings by liaising with GQRC, Pharmacovigilance (GPV&E) and other BMS department subject matter experts.
Contribute towards updating relevant sections of the Quality, Standards and Training Manual and quality related sections of the Pharmacovigilance Master File (PSMF) as appropriate
Promote the spirit of proactive, continuous quality improvement
Inspection Readiness
Assist with departmental inspections including developing responses to observations and oversight of corresponding CAPA
Trend and leverage industry intelligence relating to PV inspections and share results with teams in order to improve the effectiveness of the PV Quality System
Promote the spirit of proactive, continuous quality improvement
Qualifications Requires
Bachelors degree, Master degree Preferred, scientific/medical background(B.S./B.A, M.S.) in Life Science, Nursing, Regulatory Affairs, Chemistry or Pharmacy
Minimum of 8 years pharmaceutical experience with a strong preference of 5 or more years in pharmacovigilance, drug development, clinical development, quality and/or regulatory.
Excellent written and verbal skills
Excellent skills in influencing and collaborating in order to problem solve
Capable to interpret information/data to provide guidance regarding superior business solutions, largely in the form of influencing strong corrective and preventive actions as a result of audit/inspection findings
Ability to detect business and regulatory issues and develop solutions to mitigate risk
Self-starter with demonstrated ability to work independently and in a matrix, team environment
General understanding and adaptation of global safety regulatory obligations from clinical trial to post marketing phases
Appreciation of sense of urgency and prioritization of multiple projects and timelines
Company
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
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