Job added in hotlist
Applied job
Contract job
90-day-old-job
part-time-job
Recruiter job
Employer job
Expanded search
Apply online not available
View more jobs in Seattle, WA
View more jobs in Washington

Job Details

Associate Director Principal Product Quality Lead

Company name
Bristol-Myers Squibb Company

Location
Seattle, WA, United States

Employment Type
Full-Time

Industry
Manager, Quality, Biotech, Pharmaceutical

Posted on
Jul 24, 2020

Apply for this job






Profile

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.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Position Summary

We are seeking a Principal Product Quality Lead (Principal PQL), Associate Director of Global Product Quality. The Principal PQL will partner with the Global Product Quality Lead (GPQL) to provide direct technical and quality compliance oversight of a late-stage cell therapy vector program. The Principal PQL will be assigned oversight and decision authority over multiple aspects of the cell therapy vector program as it moves through commercialization readiness activities including commercial filing and approvals as well as life-cycle management activities. They will assist the Global PQL to develop and roll-out global product quality strategies relating to end-to-end Quality management of clinical / commercial manufacturing, life-cycle improvements (process, analytical), analytical control strategies (methods, specifications), stability, product complaints, and monthly Product Quality Team reviews. They will support implementation and risk mitigation strategies related to technology transfer, comparability, clinical filings, and life-cycle improvements (as needed). They will also be expected to collaborate with QC, QA, Manufacturing, Stability, Analytical Development, Process Development, Manufacturing Sciences and Technologies, Regulatory Affairs, and other Cell Therapy Development Organizations to ensure regulatory compliance of GMP operations in support of the vector program. This role is stationed in Summit, NJ or Seattle WA and reports to the Director, Global Product Quality, Cell Therapy Vector Programs.

Detailed Position Responsibilities

Provide global product quality oversight and support for external manufacturing / partnerships and internal manufacturing operations including developing and maintaining relationships with site QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions.

Supports the overall product quality strategy based on CMC / TCT deliverables, PD team objectives, life-cycle improvements, and regulatory commitments.

Provides technical quality expertise and compliance oversight in accordance with global regulatory requirements and internal policies in support of commercial development efforts and life-cycle management activities.

Supports Global Annual Product Quality Review deliverables for the product that include coordinating with leads of contributing chapters and ensure timely and compliant execution of the program

Review clinical and commercial regulatory filings as needed.

Serves as a delegate for the Global PQL in CMC/TCT meetings, Development team meetings, and general cell therapy governance meetings.

Coordinates Product Quality Team meetings between Global PQL, Site QA/QC, Analytical Development, Process Development, Manufacturing Sciences and Technology, Product Sciences, and Regulatory Affairs.

Coordinates product specific presentations to the Product Quality Review Board / Product Specification Committee and other product quality related cross-functional teams

Serves as QA reviewer / approver for development reports, product specifications, and product labeling

Supports Quality oversight and delegated launch readiness activities.

Provide strategic guidance and facilitate the timely implementation of global changes with respect to the product. Owns global changes and documentation management activities as required.

Assist in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical to commercial phase Qualifications and Education Requirements

BS/MS in relevant Science or Engineering discipline and 10 years of experience in Quality in a biotech, pharmaceutical, or bio-pharmaceutical organization; 1-3 years of experience in a supportive PQL role is preferred

Expertise in GMP compliance, global regulations and strong understanding of pharmaceutical product development lifecycle are required

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

Demonstrated ability in decision making and problem solving is required

Demonstrated Quality leadership through partnership in a matrixed-organization is required

Background in Biologics or Cell Therapy Manufacturing is required

Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships

Experience with review of market applications, IND, supplements or similar regulatory documentation is requiredAround 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. Company: Bristol-Myers Squibb Req Number: R1527577_EN Updated: 2020-07-24 00:00:00.000 UTC Location: Seattle,Washington

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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com

Similar Jobs:
Dist Suppt Pharmacist PT
Location : Gig Harbor, WA
Job Description Summary: Health is everything. At CVS Health, colleagues are committed to increasing access, lowering costs and improving quality of care. Millions of times a day, we help people on their path to better health—from...
Overview Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first N...
Jobs Rated 41st CLINICAL PHARMACIST - AMBULATORY PHARMACY CLINICAL SERVICES (FULL-TIME, DAY SHIFTS) Req #: 222783 Department: HARBORVIEW MEDICAL CENTER PHARMACY Job Location: Harborview Medical Center Posting Date: 05/31/2023  Cl...
I found a new job! Thanks for your help.
Thomas B - ,
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
PharmaceuticalCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
PharmaceuticalCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2024 PharmaceuticalCrossing - All rights reserved. 21 192