Shanghai, CN
1 day ago
Director, Clinical Quality (China)

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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 with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Key Responsibilities
•    Manages a team of skilled GCP compliance specialists within the assigned region   
•    Provides coaching and mentoring to direct reports through audit assignments, health authority inspections, assessment of vendor quality, training, and other experiences that broaden staff knowledge and utilizes audit experience 
•    Coordinates, conducts and/or attends audits, as applicable to evaluate team member and contractor competencies and to maintain and/or enhance own competencies/experiences 
•    Manages resources as necessary to assure that the company strategy and objectives of RDQ-CQA are achieved 
•     Provides management review of audit plans, reported findings and associated CAPA to ensure consistency and adherence to timelines stated in the RDQ-CQA procedures 
•    Identifies new or more efficient processes to perform audits 
•    Maintains in-depth knowledge of governmental regulations and industry standards within the GCP compliance functions 
•    Leads and/or supports the selection process of selecting candidates for positions within RDQ-CQA 
•    Collaborates with key stakeholders to maintain productive relationships 

Qualifications & Experience

Degree/ Certification/ Licensure: University Graduate in relevant discipline (life sciences degree preferred)  
Experience- Responsibility and minimum number of years: 
•    Demonstrated expertise and specific technical knowledge of the GCP areas subject to audit, as evidenced by at least 15 years in the pharmaceutical industry (or equivalent) and 10 years in technical auditing and/or related experience; GCP auditing preferred. 
•    8 years of experience supervising others or leading teams 
Competencies- knowledge, skills, abilities, other: 
•    Effective verbal and written communication and interpersonal relationship skills. Ability to adapt communication style to suit different audiences/cultures. Deliver clear verbal and written messages in a constructive and effective manner to a variety of audiences/recipients 
•    Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management, during the audit, inspection or process improvement process  
•    Ability to participate in the critical evaluation of quality management systems and quality operations in support of Quality culture and operational output, balancing weaknesses against requirements and expectations 
•    Good presentation skills, deliver focused message to audience of peers, stakeholders, and Regulatory Agency Inspectors 
•    Understanding of legal and business aspects related to health authority inspections outcomes 
•    Ability to impact and influence 
•    Enhances individual development by fostering career development opportunities and ensures that development plans are created and implemented for staff 
•    Profound knowledge of quality risk management. Ability to identify and escalate areas of high risk and to recommend appropriate corrective and preventive actions 
•    Demonstrates commitment to delivering high-quality work product 
•    Knowledge of relevant BMS policies and procedures 
•    Profound knowledge of regulatory requirements for clinical research and development 
•    Good understanding of the drug development process 
•    Develops strong working relationships with key stakeholders 
•    Ability to analyze complex situations, and to draw meaningful conclusions by distinguishing the details from the essence of the issue 
•    Maintains the confidentiality and security of information, data, documents, and records 
•    Able to function independently within an environment that relies heavily on technology for information and communication 
•    Sense of diplomacy and discretion 
•    Demonstrates flexibility, open-mindedness, and adaptability to a rapidly
•    changing environment 
•    Fluent in English and other languages, as applicable to assigned audit region 
•    Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective 
•    Ability to manage competing priorities 
•    Ability to lead change processes within functional group 
•    Possesses detailed knowledge of areas of expertise and could teach or mentor others 
•    Develops and applies new methods and ideas to enhance performance 
•    Software that must be used independently and without assistance: Demonstrates computer literacy; Microsoft Suite, SharePoint, Veeva Vault, RAVE, other systems as assigned/applicable  

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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