Bristol Myers Squibb QA Manager, Validation/Technical Services in Syracuse, New York

Duties/Responsibilities:

  • Contribute to team based collaborative positive environment promoting commitment to continuous improvement and achievement of aligned company objectives

  • Promote and maintain a safe working environment and participate in safety and compliance inspections

  • Facilitate site product quality position by ensuring the appropriate validation procedures are in place and conformance exists to internal and external standards/regulations

  • Collaborate with technical groups in the development of parameters within validation protocols

  • Review and approve validation, qualification, and technical transfer protocols and reports for new and existing products, processes, analytical methods, and equipment

  • Facilitate the launching of new or improved product processes, and the transfer of technology from development to commercialization from quality perspective

  • Monitor and assess product performance in meeting essential quality parameters through continual process robustness monitoring and completion of annual product reviews

  • Recognize anomalous data trends/results and drive remedial quality actions

  • Lead investigations for Quality, including QA and QC laboratory investigations that support the commercial manufacturing facility, as well as network and third party manufacturing facilities

  • Review and approve exception documentation including protocol investigation reports, event reviews, quality events and laboratory investigations to ensure a thorough root cause analysis, product impact assessment, and effective CAPA

  • Review and approve documents such as SOPs and technical reports as required

  • Drive SOP revision or new SOPs as required to maintain compliance

  • Author and drive change controls to completion for area of expertise

  • Demonstrate a quality culture, focus on scientific excellence, and provide expertise to staff and colleagues

  • Communicate business critical information to staff, providing leadership and strategic business direction

  • Manage performance of direct reports to ensure achievement of organizational and department goals

  • Maintain and communicate performance metrics, driving high expectations for team safety, compliance, and performance

  • Provide feedback, coaching, and training to enhance development of each direct report

  • Participate in and support internal audits and regulatory health authority inspections

  • Embrace harmonization initiatives/activities to assist with streamlining operations

  • Develop job function training for department

  • Actively seek to improve/obtain new technical skills and share learnings with department

  • Present information at meetings and perform other activities as requested by management

QUALIFICATIONS:

Specific Knowledge, Skills, Abilities, etc.:

  • Strong knowledge of FDA, EU and ICH regulations, guidance, and cGMPs for biopharmaceuticals

  • Excellent verbal and written communication skills

  • Demonstrated success leading cross-functional problem solving and technical teams

  • Strong project management, presentation, organization and technical writing skills

  • Ability to understand topics which are often complex and technical in nature with an ability to apply sound judgment and appropriate quality risk management principles in the decision making process

  • Strong interpersonal and personnel management skills that foster cooperation and commitment

  • Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail

  • Strong root cause investigation knowledge and experience leading quality and compliance investigations

  • Knowledge of biologics bulk and finished product manufacturing and analytical testing is highly desirable

  • Familiarity with common biotechnology assays instrumentation and equipment is highly desired, such as bioassay, B7 binding, ELISA, titer, Sialic Acid, qPCR, SEC and other chromatography based assays

  • Experience in preparing for and interacting directly with regulatory and external inspection auditors

  • Experience with human error analysis is desirable

  • Experience with SAP, LIMS, Maximo and TrackWise or equivalent quality systems is desirable

  • Knowledge of Delta V and Syncade is desirable

Education/Experience/ Licenses/Certifications:

  • Minimum of a Bachelor’s degree in engineering, chemistry, biological sciences or related discipline with 7 years of pharmaceutical experience

  • Successful demonstrated leadership, preferably with at least 3 years of management in Quality or related technical function along with increasing cross-functional responsibility

  • Preferred experience within biopharmaceutical Quality Assurance process engineering and Quality Control

  • Lean and/or Six Sigma green, black or master black belt certification is desirable

Physical Demands:

  • This position is primarily office-based work that routinely requires sitting for extended periods at computer workstations. Walking between and within buildings to collaborate with others and oversee areas of responsibility is required. This position will require unassisted lifting of items (not to exceed 50 lbs.), bending/stooping, twisting, crouching/squatting, kneeling, sitting, walking (level surfaces), reaching (shoulder), accurate vision (acuity, color – correction allowed), and repetitive use of arm, hands, wrists. This position is a team-based position that will require ensuring weekend, holiday, and overtime coverage is available when necessary.

Work Environment:

  • This position is primarily an office-based position. Requirements include routinely entering the laboratory and manufacturing floor environments to perform quality oversight activities, which may entail potential to encounter hazardous materials such as caustic, acids, and steam.

Travel:

  • This position requires up to 5% of travel

Supervisory Responsibilities:

  • Direct supervision of Quality department employees

  • Provide guidance, oversee activities, and participate in the on the job training of less experienced staff

  • Develop and grow staff to meet career and organizational development needs

  • Develop and manage succession plans for team roles

  • Experience in building, growing and transforming an organization is desirable

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled