Program Manager, Clinical QA (Remote)
Company: Takeda Pharmaceuticals
Location: Charleston
Posted on: January 21, 2023
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Job Description:
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's Privacy Notice and Terms of Use . I further attest
that all information I submit in my employment application is true
to the best of my knowledge.**Job Description****Job Title:**
Senior Program Manager, Clinical Quality Assurance,
Oncology**Location** _:_ Cambridge, MA (Remote)**About the role:**+
Responsible for leading Clinical Quality Assurance (CQA) activities
for assigned clinical development programs, including the
management of audits, quality issues and investigations, and
inspections. This position requires a depth of understanding and
experience in GCP and compliance, leadership, communication skills,
and business acumen to conduct responsibilities with minimal
supervision.+ Provide professional expertise and guidance on Good
Clinical Practice (GCP) and applicable regulations to clinical
development teams to proactively identify compliance issues/risks
and recommend mitigations+ Liaise with various Takeda R&D
functions and external parties including contract auditors and
investigator sites to promote a high level of quality and
consistency across and within programs; develop the risk-based
audit and compliance strategy for assigned programs; assist project
teams in implementing corrective and preventive actions; and enable
teams to be inspection ready, in support of a culture of
sustainable compliance.+ Manage domestic and international audits
of sites, documents, databases, vendors or internal systems in
compliance with GCP and Takeda policies and procedures; assess
impact of audit findings on subject safety, data integrity, and
business operations. Audits conducted require advanced auditing
skills and may involve technically complex assignments, including
audits of high-risk studies/vendors**How you will contribute:**+
Provide expertise in GCP compliance interpretation, consultation,
training, and recommendations to assigned program teams and
leadership+ Develop and implement program-specific risk-based audit
and compliance strategy and manage audits of sites, documents,
databases, vendors or internal systems in compliance with GCP and
Takeda policies and procedures. Audits require advanced auditing
skills and may involve technically complex assignments.+ Assess
impact of audit findings and other identified compliance risks to
subject safety, data integrity, and business operations and
escalate compliance risks to CQA management.+ Ensure audit reports
and corrective actions are developed and completed within timelines
mandated in internal procedures+ Facilitate investigations into
significant quality issues, scientific misconduct and serious
breach of GCP; facilitate identification of root cause and
development of appropriate corrective and preventive actions; track
actions and confirm effectiveness; ensure reporting of potential or
confirmed violations to regulatory authorities.+ Assist with
management of GCP health authority inspections; lead clinical
development teams in preparation for announced inspections and
provide GCP compliance technical support during inspections of
investigator sites and Takeda. Facilitate appropriate and timely
inspection responses and follow-up actions.+ Collaborate with
Quality Compliance and Systems team to identify and mitigate GCP
quality and compliance issues with potential impact across multiple
compounds, Takeda sites, or functional groups.+ Analyze, report,
and present metrics for assigned programs to development teams and
CQA management; recommend any required actions and monitor
implementation.+ Escalate systemic and/or critical problems and
recommend appropriate solutions to senior management for immediate
and long-term resolution+ Perform additional GCP related activities
upon request by CQA management**What you bring to Takeda:**+ BS/BA
required; Advanced Degree preferred.+ Minimum of 5 years of
experience in the pharmaceutical, biotechnology or related health
care industry.+ Minimum 2 years of GCP-related Quality Assurance or
relevant clinical trial experience.+ Extensive knowledge and/or
awareness of ICH GCP R2 and applicable global regulations and
guidance for clinical development+ Advanced knowledge in the
conduct and reporting of audits and the translation of findings
into corrective actions plans that mitigate risks to the company,
to safety and data integrity.+ Collaborative team player with a
positive attitude and ability to think and act quickly to identify
creative solutions to complex problems+ Effective technical writing
skills; able to write quality positions, audit reports, and
procedures.+ Excellent communication skills with ability to
negotiate and influence without authority in a matrix environment+
Strong judgment, project management and decision-making skills;
able to manage multiple projects and demanding timelines+ Superior
attention to detail and ability to analyze complex data+ GCP
Quality Assurance registration/certification preferred+ Routine
demands of an office-based environment+ Remote role with quarterly
travel to the office for various meetings, audits and inspections,
including overnight trips. Some international travel may be
required.+ Requires approximately 10% travel or less.**What Takeda
can offer you:**+ Comprehensive Healthcare: Medical, Dental, and
Vision+ Financial Planning & Stability: 401(k) with company match
and Annual Retirement Contribution Plan+ Health & Wellness programs
including onsite flu shots and health screenings+ Generous time off
for vacation and the option to purchase additional vacation days+
Community Outreach Programs and company match of charitable
contributions+ Family Planning Support+ Professional training and
development opportunities+ Tuition reimbursement**Important
Considerations:**At Takeda, our patients rely on us to deliver
quality products. As a result, we must follow strict rules in our
manufacturing facilities to ensure we are not endangering the
quality of the product. In this role, you may:+ Work in a
controlled environment requiring special gowning and wear
protective clothing over the head, face, hands, feet and body. This
may include additional hearing protection for loud areas.+ Need to
remove all make-up, jewelry, contact lenses, nail polish and/or
artificial fingernails while in the manufacturing environment.+
Work in a cold, wet environment.+ Work multiple shifts, including
weekends, or be asked to work supplemental hours, as necessary.+
Work around chemicals such as alcohol, acids, buffers and Celite
that may require respiratory protection.**More about us:**At
Takeda, we are transforming patient care through the development of
novel specialty pharmaceuticals and best in class patient support
programs. Takeda is a patient-focused company that will inspire and
empower you to grow through life-changing work.Certified as a
Global Top Employer, Takeda offers stimulating careers, encourages
innovation, and strives for excellence in everything we do. We
foster an inclusive, collaborative workplace, in which our teams
are united by an unwavering commitment to deliver Better Health and
a Brighter Future to people around the world.This posting excludes
Colorado applicants._Base Salary Range: $130,200 - $186,000 based
on candidate professional experience level. Employees may also be
eligible for Short Term and Long-Term Incentive benefits as well.
Employees are eligible to participate in Medical, Dental, Vision,
Life Insurance, 401(k), Charitable Contribution Match, Holidays,
Personal Days & Vacation, Tuition Reimbursement Program and Paid
Volunteer Time Off._\#GMSGQ\#ZR1\#LI-MA1**EEO Statement**_Takeda is
proud in its commitment to creating a diverse workforce and
providing equal employment opportunities to all employees and
applicants for employment without regard to race, color, religion,
sex, sexual orientation, gender identity, gender expression,
parental status, national origin, age, disability, citizenship
status, genetic information or characteristics, marital status,
status as a Vietnam era veteran, special disabled veteran, or other
protected veteran in accordance with applicable federal, state and
local laws, and any other characteristic protected by
law._**Locations**Boston, MA**Worker Type**Employee**Worker
Sub-Type**Regular**Time Type**Full time\#LI-Remote
Keywords: Takeda Pharmaceuticals, Charleston , Program Manager, Clinical QA (Remote), Executive , Charleston, West Virginia
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