Senior Director, Global Product Quality Lead, Cell Therapy
Company: Bristol-Myers Squibb Company
Location: Summit
Posted on: August 7, 2022
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Job Description:
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.Location: Summit NJ, Seattle
WA or Devens MACell Therapy is one of the most groundbreaking new
forms of cancer treatments being studied today. With therapies only
in their infancy, the growth potential of the science - and its
ability to help patients - is incredible.Scope of the roleThe
Senior Director, Cell Therapy Global Product Quality Lead (Sr. Dir.
CT-GPQL) is accountable for delivering commercially robust and
globally compliant quality strategies and outcomes that sustain the
product supply chain throughout the product lifecycle. Manages
product quality risk throughout the product lifecycle, including
oversight of process and analytical lifecycle, control strategies,
comparability, specifications, and stability. Monitors commercial
operations through periodic reviews of process and method
performance, including Annual Product Quality Reviews. Provides
general support and leadership within the Global Product Quality
organization. Authors designated sections of regulatory filings,
reviews all sections for clarity, technical persuasiveness,
consistency and completeness, and serves as a subject matter expert
and strategist during health authority inspections. The scope of
the role includes one or more cell therapy programs
(clinical/commercial), encompassing the internal and external
manufacturing and testing of cell banks, gene delivery materials,
drug product intermediates, drug product, and finished labeled drug
product.This role can be in Seattle, WA, Summit, NJ or Devens, MA
and reports to the Head of Global Product Quality, Cell
Therapies.Key responsibilities:The Senior Director, Cell Therapy
Global Product Quality Lead will lead a team of Product Quality
Leaders to:Partner across Global Product Quality, Analytical
Sciences and Technology, CT Development, CT Operations, and CT
Regulatory CMC to define and deliver product quality strategies
that comply with internal and external quality standards and
regulatory requirements.Provide global product quality oversight of
assigned areas of responsibility and support manufacturing
operations including developing and maintaining relationships with
partner organizations.Supports the overall Quality plan based on
Cell Therapy Development and Operations annual goals, critical
projects, and/or life-cycle support for Product Team objectives,
regulatory commitments, and process and product monitoring
KPIs.Provide quality expertise in accordance with global regulatory
requirements and internal policies in support of product
characterization, product specifications, method validation,
stability and comparability assessments for manufacturing and site
changes.Drive timely and compliant completion of the Annual Product
Quality Review ensuring coordination with leads of
contributing.Perform Quality review of CMC sections of regulatory
submissions and responses. May author CMC sections or responses to
queries, as needed.Represent Quality in CMC meetings with global
regulatory agencies and during regulatory inspections.Represent
Quality on the CMC and GO-CT teams.Act as QA approver for product
specifications and product labeling as needed.Provide supportive
quality oversight and guidance during product launch to program
teams.Provide strategic guidance and facilitate the timely
implementation of manufacturing and testing changes. May own 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.Influence industry
and health authorities and ensure staff present at external
conferencesIdentify and mentor future leadersThis role will partner
with Analytical Sciences and Technology, Process and Analytical
Development, Manufacturing Sciences and Technologies, Stability,
Quality Assurance, Quality Control, GRS CMC to develop and execute
product quality strategies.Professional experience and
qualifications Master's or PhD degree in Biochemistry, Immunology,
Molecular Biology, Chemistry, Biology or corresponding engineering
discipline preferredAt least 12 years of experience in cell
therapy, pharmaceutical and/or biotechnology fields in
Manufacturing Operations or Quality rolesKnowledge and Skills: The
Sr. Dir. CT-GPQL, in the nascent field of cell therapy, must be
skilled in the development of quality strategies with little
external guidance, ensuring product quality throughout the
lifecycle. The Sr. Dir. CT-GPQL is a motivated, engaged,
solutions-driven, strategic, and adaptable leader who supports the
ED CTQ GPQ and the senior Cell Therapy Leadership Team, in the
advancement of quality readiness. In particular, the Sr. Dir.
CT-GPQL has:Expertise in GMP compliance, global regulations, and
strong understanding of pharmaceutical product development
lifecycle, with specific emphasis on gene delivery and cell therapy
preferred.Experience authoring, reviewing, and representing Quality
in support of both clinical and commercial regulatory submissions
across multiple domestic and international
jurisdictions.Demonstrated decision making and problem-solving
capabilities relative to Quality, compliance, technical
considerations, and regulatory requirementsDemonstrated Quality
leadership through partnership in a matrixed organization is
requiredWorking background in Biologics, Gene Delivery, or Cell
Therapy ManufacturingDemonstrated 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 Experience
implementing quality strategy and standardsDirect experience
participating in interactions with global regulatory agencies and
in the preparation of regulatory submissionsDemonstrated ability to
develop technical and strategic leadership talent to meet current
and future business needsStrategic thinker who sees the bigger
picture and possesses high business acumen; understands how the
parts impact the whole (end to end enterprise) and makes the best
decisions for the wholeExcellent influence and negotiation
experience and capability in a matrix environmentAble to interact
with senior leaders from both Cell Therapy Development and
Operations and GPS in this capacity and as such is seen as a highly
regarded and a credible leader with the ability to act on behalf of
the ED of CTQ to interface with stakeholders in a matrix
environmentThe ability to anticipate and effectively influence
future trends in the industry.Additional professional and personal
requirements include:Strong organizational skills, ability to
multitask and work in a dynamic, fast paced environment.Experience
in leading change and a demonstrated ability to accomplish results
and meet deadlines and commitments.Strong collaboration, delegation
and interpersonal communications skills to enable sharing critical
information with project team and senior leaders.Demonstrated
analytical and logical skills with a focus on fact-based decision
making.Ability to build strong, trusting relationships, lead
large/complex teams, and work across divisions, diverse business
backgrounds and culturesExcellent communication and interpersonal
skills, with the ability to interface with a broad range of
internal and external stakeholders at all levels of the
organizationTravel: This role requires about 10% travel.If you want
to advance your career and give new hope to patients, there's no
better place than here with our Cell Therapy team. Full of
incredible and dedicated team members, those working on CAR-T and
other forms of Cell Therapy are transforming patients' lives
through science. From studying individualized cell lines to making
brand new discoveries, this bold and personal discipline allows you
to grow your career while making a lasting impact on the field of
medicine. Join us today.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.
Physical presence at the BMS worksite or physical presence in the
field is an essential job function of this role which the Company
deems critical to collaboration, innovation, productivity, employee
well-being and engagement, and enhances the Company culture.To
protect the safety of our workforce, customers, patients and
communities, the policy of the Company requires all employees and
workers in the U.S. and Puerto Rico to be fully vaccinated against
COVID-19, unless they have received an exception based on an
approved request for a medical or religious reasonable
accommodation. Therefore, all BMS applicants seeking a role located
in the U.S. and Puerto Rico must confirm that they have already
received or are willing to receive the full COVID-19 vaccination by
their start date as a qualification of the role and condition of
employment. This requirement is subject to state and local law
restrictions and may not be applicable to employees working in
certain jurisdictions such as Montana. This requirement is also
subject to discussions with collective bargaining representatives
in the U.S.Our company is committed to ensuring that people with
disabilities can excel through a transparent recruitment process,
reasonable workplace adjustments and ongoing support in their
roles. Applicants can request an approval of accommodation prior to
accepting a job offer. If you require reasonable accommodation in
completing this application or if you are applying to a role based
in the U.S. or Puerto Rico and you believe that you are unable to
receive a COVID-19 vaccine due to a medical condition or sincerely
held religious belief, during or any part of the recruitment
process, please direct your inquiries to
adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility
to access our complete Equal Employment Opportunity statement.Any
data processed in connection with role applications will be treated
in accordance with applicable data privacy policies and
regulations.
Keywords: Bristol-Myers Squibb Company, New York , Senior Director, Global Product Quality Lead, Cell Therapy, Executive , Summit, New York
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