Associate Director, Clinical and Safety Quality Compliance

BioSpace; Boston (MA); On-site; USD 153,000 - 242,000; Full time

Job summary

A leading biotech company is hiring for the position of Associate Director in Clinical and Safety Quality Compliance. This role is crucial for ensuring product quality through compliance with regulatory standards, involving significant responsibilities in process auditing, regulatory intelligence, and quality system improvements.

Benefits

Medical, dental, and vision insurance

401(k) plan with company match

Tuition reimbursement program

Paid volunteer time off

Generous vacation policy

Qualifications

• Minimum of 7 years of experience in the global pharmaceutical industry.
• 3 years of experience in GCP Quality/Compliance.
• Experience in managing complex organizational compliance issues.

Responsibilities

• Ensure compliance to Regulatory Intelligence Processes with CPMP.
• Oversee the review and closure of change controls.
• Provide insights on continuous improvement projects.

Skills

Regulatory Compliance

Auditing

Quality Assurance

Communication

Critical Thinking

Education

BSc in a scientific or allied health/medical field

Job description

Associate Director, Clinical and Safety Quality Compliance

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Associate Director, Clinical and Safety Quality Compliance

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Job Description

About the role:

The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of processes and product outputs. This role involves defining and specifying activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's mission to provide better health and a brighter future.

How Will You Contribute

• Ensure compliance to Regulatory Intelligence Procedures by executing the regulatory intelligence process in partnership with functional compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and determined by compliance to regulatory intelligence procedures.
• Ensures a robust communication plan is in place (including brief description of the new and or revised regs, the impact, any risks, mitigation plans, timelines) that enables knowledge sharing of regulatory intelligence insights and risks across CPMQ. Communicates to CPMQ periodically the progress of new and revised regulations and impact.
• Ensure implementation of change control and actions completed to address new and revised regulations. Oversees the review, completion and closure of routine and complex, impactful strategic clinical-related change controls and strategic Pharmacovigilance-related change controls.
• Provides data insights to emerging regulations and requirements, operational and compliance metrics and storyboards, identifies quality and compliance risks, and proactively provides strategic and tactical directions in the mitigation.
• Actively participate and contribute to enterprise-wide projects and initiatives, ensuring insights related to clinical and safety quality are considered.
• Enable a compliant quality system in safety and clinical trial delivery systems via CPMQ continual improvements projects. Actively participate and represent in continual improvement projects, related to safety and clinical trial delivery in partnership with GDO, PSPV, GRA etc. Review the outputs of the safety and clinical trial delivery redesigned processes and coordinate CPMQ colleague’s input.
• Provide CPMQ insights on continuous improvement that are enterprise-wide (ie Veeva, QMS, Enterprise Audit, etc.) to Global Quality and R&D Quality. Present to CPMQ at periodic intervals the status, insights and impact of projects impacting clinical and safety quality.
• Actively identifies key areas for process improvements and develop and execute plans according to timelines. Support the implementation of new and revised processes across CPMQ.
• Contributing to the design, implementation and advancement of the Clinical and Safety Quality Compliance strategy, model, and operations as a key member of the Leadership Team.
  
  
  

What You Bring To Takeda

• 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 in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality/Compliance.
• Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.
• Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, investigations 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.
• Successful management of business transformation/change management initiatives e.g. quality system integration, outsourcing strategy etc
• Excellent communication skills to convey message. Exceptional active listening skills to understand the needs and concerns of others, which is crucial for finding win-win solutions.
• Outstanding ability to apply critical thinking and problem-solving abilities to address challenges and advocate for solutions.
• Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues.
• Fluency in written and spoken English, additional language skills a plus.
  
  
  

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Takeda Compensation And Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range

$153,600.00 - $241,340.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

LocationsBoston, MACHE - Glattpark (Opfikon) - Zurich HQ

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Internet News

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