Associate Manager, Equipment Commissioning Qualification (ECQ) Delivery
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
PURPOSE AND SCOPE OF POSITION:
The Associate Manager, Equipment Commissioning & Qualification Delivery supports the successful operation of facility, laboratory and business functions at multi‐use sites through interaction with internal team members and peer‐level customers as well as external service providers. The incumbent in this role supervises entry, junior, and experienced level professionals to accomplish daily tasks and short‐term projects according to established policies and procedures. The individual manages multiple projects and ongoing work activities of low to moderate complexity to ensure on time completion. In addition to answering questions and resolving issues for staff, the incumbent spends a small portion of their time on individual work. The incumbent may recommend modifications to work processes or procedures to functional management that impact their immediate function or organizational unit.
DUTIES AND RESPONSIBILITIES
1) Management Responsibilities:
- Lead a team of up to 10 people.
- Assist with interviewing internal and / or external personnel to fill necessary roles.
- Provide direction to internal and external team members.
- Manage the workload of team members to ensure appropriate work life balance.
- Delegate, develop and motivate direct and contract reports.
- Set goals for and deliver personnel performance reviews for direct reports.
- Ensure team members are appropriately trained for duties being performed.
- Promote and ensure the safety of all team members and adherence to site EHS procedures and guidelines.
- Ensure the team is in full compliance with local, site and global Celgene policies and procedures.
2) Commissioning and Qualification Activities
- Directly manage Equipment Commissioning & Qualification equipment qualification teams.
- Manage and allocate resources responsible for teams performing validation activities of new equipment and standalone laboratory computerized systems and/or changes to existing equipment and standalone computerized systems.
- Manage project teams with emphasis on solutions to technical and compliance challenges in all phases of the System Lifecycle.
- Oversee the Development/Review/Approval of SOPs, WPs, test protocols, validation deliverables and plans as needed.
- Ensure resources performing validation activities are knowledgeable of and in tune with latest industry regulations and initiatives.
- Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.
3) Promotes and provides excellent customer service and support
- Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
- Provides technical support and guidance on equipment and computer systems qualification and validations issues. Interfaces with customers to ensure all expectations are being met.
- Maintains a positive relationship with all the members of the Equipment
- Commissioning & Qualification department and site customers while promoting a positive team environment.
4) Communication and Management of Timelines
- Manage staff workload of multiple projects and priorities across the many different departments that the ECQ organization serves.
- Develop an effective mechanism for communicating the current status of all laboratory systems maintained by ECQ to all affected stakeholders.
- Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.
5) Regulatory Responsibilities
- Ensure equipment, facilities and programs are maintained in compliance.
- Act as departmental lead and SME in both internal and regulatory audits.
EDUCATION AND EXPERIENCE
- Bachelor's degree in an applicable discipline
- Minimum of 5 years of experience in FDA-regulated industry.
- Minimum of 5 years of experience managing personnel and/ or projects.
- Strong instrumentation background and experience in laboratory and manufacturing operations.
- Knowledge of cGMP in the pharmaceutical industry.
- Experience with the validation/qualification of facilities, utilities, equipment, and lab computer systems in a GMP environment.
- Experience authoring/review/approval of validation deliverables (Plan, URS, RA, IQ, OQ, PQ, UAT, RTM, CS, Report).
- Experience with Change control, deviations, investigations, CAPA.
- Excellent computer skills including knowledge of calibration management and environmental monitoring systems
- Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
- Experience interacting with regulatory agents, external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions.
- Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required
- Must have supervisory/team leading experience, supervising direct reports preferred.
Knowledge, Skills & Abilities:
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
- Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support cell therapy clinical manufacturing
- Ability to develop, delegate and motivate others including direct and indirect reports.
- Understanding of scheduling fundamentals and execution.
- Strong written and verbal communication skills.
- Excellent interpersonal skills with experience dealing with a diverse workforce.
- Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
- Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and
- Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
- Working knowledge of scheduling software and systems, and inventory management systems.
- Ability to create and analyze meaningful metrics.
- Professional Knowledge
- Problem Solving
- Team Player / Building Relationships
- Customer Focus
- Action and detail oriented
- Active Listening
WORKING CONDITIONS: (US Only)
PHYSICAL /MENTAL DEMANDS: (US Only)
- Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.
- Ability to sit, stand, walk and move within workspace for extended periods.
- Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.
ENVIRONMENTAL CONDITIONS: (US Only)
- Primarily office environment but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
- Ability to work safely and effectively when working alone or working with others.
This job description is intended to describe the general nature and level of work being performed by the
person assigned to this position. The primary duties and responsibilities are intended to describe those
functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities
assigned to this position. There are other duties and responsibilities that are considered incidental or
secondary to the overall purpose of this job. Employees holding this position will be required to perform
any other job-related duties as requested by management.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.