Head of Quality
Company: Promote Project
Location: New York
Posted on: March 14, 2025
Job Description:
Roivant's mission is to systematically reduce the time, cost,
and risk of delivering new medicines to market by accelerating the
development of promising drug candidates to improve the lives of
patients and their families. Since its inception in 2014, Roivant
has achieved the following critical milestones in support of its
vision: built over 20 portfolio companies (Vants); 5 successful
IPOs; 10 consecutive positive phase 3 trials; 6 FDA approvals; >
10$B in global pharma partnerships and proceeds; expanding pipeline
of assets across various modalities and therapeutic areas;
successful commercial launch of VTAMA, (tapinarof) cream, 1%, for
the topical treatment of plaque psoriasis in adults. Building upon
this track record of establishing a robust pipeline through
in-licensing and acquisition of novel assets and technology
platforms, Roivant is currently building new capabilities in drug
discovery and expanding upon existing development disciplines to
become the leading tech-enabled pharmaceutical company.As the
centralized engine for innovation and development the Roivant
R&D team is responsible for: 1) discovery efforts focused on
integrating computational and medicinal chemistry methods in order
to establish R&D leadership positions in oncology, immunology
and rare diseases; 2) working hand in hand with Business
Development to establish the scientific rationale and development
strategy for in-licensing opportunities; 3) providing tactical and
strategic R&D support to stand up new portfolio companies
(Vants) and advance development efforts across the
portfolio.Roivant is seeking a highly motivated Senior Director,
Head of Quality, to develop and implement quality systems and
oversee the function for the parent company and new co creation.
S/He must work collaboratively across and between functions,
geographies, and organizational levels to ensure Roivant is well
positioned to anticipate and mitigate risks associated with
clinical programs, product manufacture and regulations.Key
Responsibilities:
- Responsible for the development, implementation, and strict
adherence to a GxP quality program.
- Develop phase appropriate processes and procedures for Roivant
as well as select Vants, as needed.
- Primary employee responsible for Quality decisions and
execution on GMP, GCP, systems, qualification etc.
- Oversee the drug substance, drug product,
packaging/labeling/serialization, third-party logistics vendors for
production activities of early and late-phase therapeutic
areas.
- Review and approve specifications affecting product quality and
oversee the development of batch records, validation protocols.
-
- Reviews and resolves quality issues with stakeholders and
others including vendors, internal customers and production
personnel.
- Schedules and performs, as applicable, quality audits and
reports findings to the company; ensures corrective action plans
are developed there is a timely resolution of findings.
- Prepares Quality Metrics for senior leadership supporting the
quality function.
- Ensure the appropriate Quality Management Systems in place to
ensure GxP compliance. -
- Develop mutually agreeable Quality Agreements with Tier 1
vendors and vants. Support inspection readiness activities and
associated Health Authority Inspections.
- Develop/implement department specific standards and SOPs in
support of the Quality System to satisfy best practices and
regulatory requirements.
- Work with management of GxP-regulated internal groups to
identify process improvements for building compliance into the
design and conduct of clinical activities.
- Collaborate to ensure management of GxP regulated internal
groups are actively engaged in improving compliance and addressing
compliance risks. -
- Evaluate GxP compliance status in relationship to industry and
Regulatory Agency expectations and assesses the effectiveness of
corrective actions in response to internal and third-party
audits.Requirements:
- Bachelor's Degree is required in Biological Science, Chemistry
or related technical discipline.
- 15+ years' experience in Biotech/Pharmaceutical industry, with
ideally a minimum of 10 years in a supervisory capacity.
- Expert working knowledge and interpretation of FDA/EU and ICH -
GCP regulations and guidelines.
- Broad and direct experience with regulatory authority
inspections.
- Strong experience working with outsourced support with track
record of collaboratively engaging with external GxP 3rd parties to
effectively execute Quality oversight.
- Experienced in all phases of drug development is a plus.
- Flexible in the face of shifting needs and/or priorities.
- Able to interface well with all levels of personnel, including
peers and other department heads such as: Clinical, Safety, Data
Management, Biostatistics, Regulatory, CMC, and Project
Management.
- Experience with computerized systems and their associated
compliance requirements.
- Capacity to produce high quality results across multiple
projects and demands, through effective prioritization, while
working under short deadlines associated with a fast-paced dynamic
scientific environment.
- Excellent communications skills, both written and verbal.
- Excellent teamwork, interpersonal skills and negotiation
skills, both internally and externally.
- Strategic thinker, open-minded and flexible to adopting new
ideas.Roivant Sciences provides equal employment opportunities to
all employees and applicants for employment and prohibits
discrimination and harassment of any type without regard to race,
color, religion, age, sex, national origin, disability status,
genetics, protected veteran status, sexual orientation, gender
identity or expression, or any other characteristic protected by
federal, state or local laws.We will not accept unsolicited resumes
nor outreach from agencies. Please do not send agency resumes to
our website or Roivant Sciences and affiliated employees. Thanks!
Head of Quality LocationNew York City, New York, United
StatesSalary67500 - 110000 a year (US Dollars)DescriptionRoivant's
mission is to systematically reduce the time, cost, and risk of
delivering new medicines to market by accelerating the development
of promising drug candidates to improve the lives of patients and
their families. Since its inception in 2014, Roivant has achieved
the following critical milestones in support of its vision: built
over 20 portfolio companies (Vants); 5 successful IPOs; 10
consecutive positive phase 3 trials; 6 FDA approvals; > 10$B in
global pharma partnerships and proceeds; expanding pipeline of
assets across various modalities and therapeutic areas; successful
commercial launch of VTAMA, (tapinarof) cream, 1%, for the topical
treatment of plaque psoriasis in adults. Building upon this track
record of establishing a robust pipeline through in-licensing and
acquisition of novel assets and technology platforms, Roivant is
currently building new capabilities in drug discovery and expanding
upon existing development disciplines to become the leading
tech-enabled pharmaceutical company.As the centralized engine for
innovation and development the Roivant R&D team is responsible
for: 1) discovery efforts focused on integrating computational and
medicinal chemistry methods in order to establish R&D
leadership positions in oncology, immunology and rare diseases; 2)
working hand in hand with Business Development to establish the
scientific rationale and development strategy for in-licensing
opportunities; 3) providing tactical and strategic R&D support
to stand up new portfolio companies (Vants) and advance development
efforts across the portfolio.To learn more about our story and
company culture, please visit us at -https://roivant.com/ Position
Summary:Roivant is seeking a highly motivated Senior Director, Head
of Quality, to develop and implement quality systems and oversee
the function for the parent company and new co creation. S/He must
work collaboratively across and between functions, geographies, and
organizational levels to ensure Roivant is well positioned to
anticipate and mitigate risks associated with clinical programs,
product manufacture and regulations.Key Responsibilities:
- Responsible for the development, implementation, and strict
adherence to a GxP quality program.
- Develop phase appropriate processes and procedures for Roivant
as well as select Vants, as needed.
- Primary employee responsible for Quality decisions and
execution on GMP, GCP, systems, qualification etc.
- Oversee the drug substance, drug product,
packaging/labeling/serialization, third-party logistics vendors for
production activities of early and late-phase therapeutic
areas.
- Review and approve specifications affecting product quality and
oversee the development of batch records, validation protocols.
-
- Reviews and resolves quality issues with stakeholders and
others including vendors, internal customers and production
personnel.
- Schedules and performs, as applicable, quality audits and
reports findings to the company; ensures corrective action plans
are developed there is a timely resolution of findings.
- Prepares Quality Metrics for senior leadership supporting the
quality function.
- Ensure the appropriate Quality Management Systems in place to
ensure GxP compliance. -
- Develop mutually agreeable Quality Agreements with Tier 1
vendors and vants. Support inspection readiness activities and
associated Health Authority Inspections.
- Develop/implement department specific standards and SOPs in
support of the Quality System to satisfy best practices and
regulatory requirements.
- Work with management of GxP-regulated internal groups to
identify process improvements for building compliance into the
design and conduct of clinical activities.
- Collaborate to ensure management of GxP regulated internal
groups are actively engaged in improving compliance and addressing
compliance risks. -
- Evaluate GxP compliance status in relationship to industry and
Regulatory Agency expectations and assesses the effectiveness of
corrective actions in response to internal and third-party
audits.Requirements:
- Bachelor's Degree is required in Biological Science, Chemistry
or related technical discipline.
- 15+ years' experience in Biotech/Pharmaceutical industry, with
ideally a minimum of 10 years in a supervisory capacity.
- Expert working knowledge and interpretation of FDA/EU and ICH -
GCP regulations and guidelines.
- Broad and direct experience with regulatory authority
inspections.
- Strong experience working with outsourced support with track
record of collaboratively engaging with external GxP 3rd parties to
effectively execute Quality oversight.
- Experienced in all phases of drug development is a plus.
- Flexible in the face of shifting needs and/or priorities.
- Able to interface well with all levels of personnel, including
peers and other department heads such as: Clinical, Safety, Data
Management, Biostatistics, Regulatory, CMC, and Project
Management.
- Experience with computerized systems and their associated
compliance requirements.
- Capacity to produce high quality results across multiple
projects and demands, through effective prioritization, while
working under short deadlines associated with a fast-paced dynamic
scientific environment.
- Excellent communications skills, both written and verbal.
- Excellent teamwork, interpersonal skills and negotiation
skills, both internally and externally.
- Strategic thinker, open-minded and flexible to adopting new
ideas.Roivant Sciences provides equal employment opportunities to
all employees and applicants for employment and prohibits
discrimination and harassment of any type without regard to race,
color, religion, age, sex, national origin, disability status,
genetics, protected veteran status, sexual orientation, gender
identity or expression, or any other characteristic protected by
federal, state or local laws.We will not accept unsolicited resumes
nor outreach from agencies. Please do not send agency resumes to
our website or Roivant Sciences and affiliated employees.
Thanks!
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job Tags
Keywords: Promote Project, New York , Head of Quality, Other , New York, New York
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