- Provide global product quality oversight over assigned areas of responsibility and support manufacturing operations including developing and maintaining relationships with other QA, QC, development, analytical, manufacturing sciences and technology, and regulatory functions.
- Supports the overall product quality plan based on Product Development Team objectives, regulatory commitments, and process and product monitoring KPIs as directed by the Global PQL.
- Assists and may provide quality expertise in accordance with global regulatory requirements and internal policies in the creation of product characterization, product specifications, method validation, stability and comparability assessments for tech transfers
- Supports Global Annual Product Quality Review deliverables (as required) that may include coordinating with leads of contributing chapters and ensure timely and compliant execution of the program
- May act as author or Quality reviewer of CMC sections of regulatory submissions and response to global agencies queries; may author CMC sections or responses to queries, as needed.
- May represent Global Product Quality in CMC meetings with global regulatory agencies and during regulatory inspections
- May represent Quality in the Global CMC and Commercialization teams
- Supports the Product Specification Committee relating to program specific topics, and other product quality related cross-functional teams
- Act as QA approver for product specifications and product labeling
- Provides supportive quality oversight and guidance during product launch
- Provide strategic guidance and facilitate the timely implementation of global changes with respect to the assigned product.
- Assist in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical to commercial phase
- BS/MS in relevant science or engineering discipline and 7 years of experience in a relevant discipline in a pharmaceutical or bio-pharmaceutical organization; 1-3 years of experience in a PQL role is preferred
- Expertise in GMP compliance, global regulations and strong understanding of pharmaceutical product development lifecycle are required
- Experience with authoring and review of market applications, IND, supplements or similar regulatory documentation is required
- Demonstrated ability in decision making and problem solving is required
- Demonstrated Quality leadership through partnership in a matrixed-organization is required
- Background in biologics, viral vector, or cell therapy is required
- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
- Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment.
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Associate Director, Principal Product Quality Lead, Cell Therapy - Summit, United States - Bristol-Myers Squibb
Description
Working with Us
Challenging. Meaningful. Life-changing. Those arent 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.
Youll 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:
.
Position Summary
Bristol Myers Squibb is seeking an Associate Director, Principal Product Leader within the Cell Therapy Global Product Quality organization.
The Principal PQL will support the Global Product Quality Lead (PQL) by providing supportive quality oversight of the assigned program from late clinical development phase through commercialization / launch and entire lifecycle.
The Principal PQL assists the Global PQL to develop and implement global product quality strategies relating to manufacturing, development, control strategies, stability, product complaints, etc.
to minimize product quality risks during product development, technology transfer, and commercial operations.The Principal PQL supports efforts to establish collaborations between Regulatory Affairs, Process Development, MS&T, Analytical Development, Site Quality (QA/QC) and Internal/External Operations to ensure regulatory compliance of GMP operations in support of the assigned program.
This role can be stationed either in Seattle, WA, Summit NJ or Devens, MA and reports to the Global Product Quality Leader, Cell Therapies.
Key Responsibilities
Qualifications & Experience
_If you come across a role that intrigues you but doesnt perfectly line up with your resume, we encourage you to apply anyway.
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.
. Visit )
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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R
Updated: :25:28.929 UTC
Location: Summit-NJ
Bristol Myers Squibb is an equal opportunity employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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