Associate Director, Quality Assurance Audit & Pharmacovigilance Business Partner (Remote)
Company: Takeda
Location: Boston
Posted on: March 21, 2023
Job Description:
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with Takeda's and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionJob Title: Associate Director, Quality
Assurance Audit & Pharmacovigilance Business PartnerLocation:
Cambridge, MA (Remote)OBJECTIVES/PURPOSE:
- Contributes tostrategic quality oversight activities of PV
business partners and suppliers that promotes operational and
compliance excellence, quality risk management and knowledge
management
- Experience in pharmacovigilance and quality management system
auditing, project management and operational knowledge of an audit
program and management of the day-to-day priorities of the BPSQA
audit program by problem solving, addressing complex challenges,
identifying risks, escalating issues to senior management,
communicating expectations to internal and external stakeholders,
and onboarding junior staff while understanding Takeda's business
priorities and needs with the business partners and suppliers
- Conducts end-to-end audit operations and ensures the timely and
compliant execution of the BPSQA auditprogram by providing
pharmacovigilance and quality assurance expertise
- Support partnerships with internal stakeholders, understanding
Takeda's business priorities and needs with the business partners
and suppliers and communicating actionable insights from the BPSQA
audit program and vendor quality management and oversight
forum
- Reports to the Head of BPSQA and contributes to the development
and implementation of BPSQA audit programAccountabilities:
- Supports senior management with the strategic quality oversight
activities of strategic business partners and suppliers through the
review of controlled procedures and templates related to PV
business partner and supplier oversight activities including PVAs,
Quality Agreements, Quality Plans, etc., to ensure regulatory and
past inspection commitments are considered.
- Assists senior management with systemic quality event
investigations relevant to business partners and suppliers that
impact the pharmacovigilance system in identifying quality and
compliance risks, contributing to robust investigations and
assisting with adequate corrective and preventive actions (CAPAs)
development, ensure continual improvement that is aligned to
Takeda's values and strategic priorities in collaborate with
different functions across the globe
- Provides input across R&D Quality functions to support the
consultant auditor framework, supplier qualification activities,
cross functional initiatives, process improvement initiatives and
participate in complex compliance projects and act as the BPSQA
point of contact to consultant auditor firms
- Executes the operational level activities for audit
preparation, scheduling, audit scope, audit sampling, audit
planning, audit conduct, audit response report and CAPA
plandevelopment of individual PV routine, qualification and/or
directed audits of businesspartners and suppliers and support
directed auditsand ensure any risks are escalated the management
and Head of BPSQA
- Oversee the accuracy and management of audit data and closure
of CAPAs and Effectiveness Checks within the audit management
system
- Contributes input to the strategic and tactical level BPSQA
risk-based audit program and communicate the updates to the annual
program and ensure any risks are communicated to the Head of
BPSQA
- Contributes to the relevant metrics and Key Performance/Quality
Indicators (KPI/KQI) of the BPSQA audit program. Mitigates,
communicates, and escalates any risks flagged by the metrics and
KPIs/KQIs, ensuring actions are commensurate to the risk and
timely.
- Ensure any risks are communicated to the Head of BPSQA.
- Provides pharmacovigilance and quality assurance expertise and
support inspections and business partner audit activities by
engagement with internal/external stakeholders
aboutinspection/audit deliverables, timely notifications, and
communications and documentrequests
- Support cross-functional continual improvements projects that
enable a compliant quality systems in the pharmacovigilance
systems.
- Partners with senior management to develop audit standardized
functional tools and processes (internal request documents, audit
plans, audit agenda and audit questionnaire templates), lead the
peer review of audit report, interface with lead auditor to resolve
and/or address audit report changes
- Act as a delegate to the BPSQA LeadEDUCATION, BEHAVIOURAL
COMPETENCIES AND SKILLS:
- BSc in a scientific or allied health/medical field (or
equivalent degree).
- Minimum of 7 years of increasing responsibility and relevant
experience in the global pharmaceutical industry, with at least 5
years of experience in GCP/GVP Quality/Compliance.
- Advanced knowledge of pharmaceutical development, medical
affairs andGCP/GVP regulations including FDA, EU, MHRA, PMDA and
ICH.
- Advance knowledge in strategic and non-strategic supplier
quality oversight
- Experience must include successful development and
implementation of a pharmacovigilance audit program,
hosting/leading business partner audits and remediation activities
on a global level.
- Experience in managing complex organizational compliance issues
and in identifying and implementing organization-wide compliance
initiatives.
- Skilled in managing global, cross-functional projects.
- Demonstrated proficiency in negotiation and conflict resolution
with stakeholders.
- Ability to navigate a fast-paced and dynamic environment with
organization and prioritization skills to meet established
timelines.
- Fluency in written and spoken English, additional language
skills a plusWhat 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 reimbursementImportant 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.Base Salary Range:
$143,500 to $200,000. Employees may also be eligible for Short Term
and Long-Term Incentive benefits. 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. The
final salary offered for this position may take into account a
number of factors including, but not limited to, location, skills,
education, and
experience.#pharmacovigilance#pv#gpv#gcp#GMSGQ#ZR1#LI-LR1EEO
StatementTakeda 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.LocationsBoston, MAZurich, SwitzerlandWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda, Boston , Associate Director, Quality Assurance Audit & Pharmacovigilance Business Partner (Remote), Executive , Boston, Massachusetts
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