Associate Director, Clinical & Quality Process Compliance

BioSpace; Boston (MA); Hybrid; USD 153.600 - 241.340; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) match

Paid vacation

Tuition reimbursement

Zusammenfassung

A leading global pharmaceutical company is seeking an Associate Director for Clinical & Quality Process Compliance. This role involves ensuring high-quality standards across processes and compliance with regulatory requirements. The ideal candidate will have significant experience in the pharmaceutical industry, particularly in Clinical Operations and GCP Quality. Responsibilities include managing regulatory procedures and leading compliance initiatives. Competitive salary and robust benefits package offered.

Qualifikationen

• Minimum of 7 years of responsibility in the global pharmaceutical industry.
• At least 3 years of experience in GCP Quality/Compliance.
• Advanced knowledge of FDA, EU, and GCP regulations.

Aufgaben

• Ensure compliance with Regulatory Intelligence Procedures.
• Maintain a robust communication plan regarding regulations.
• Provide data insights to regulatory compliance metrics.

Kenntnisse

Excellent communication skills

Critical thinking

Project management

Fluency in English

Ausbildung

BSc in a scientific, allied health, or medical field

Jobbeschreibung

Associate Director, Clinical & Quality Process Compliance

Location: Cambridge, MA – Hybrid (not remote). Relocation benefit available.

Job Description

The Associate Director, Clinical & Quality Process 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.

Responsibilities

• Ensure compliance with 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.
• Maintain a robust communication plan that includes brief descriptions of new or revised regulations, impact assessment, risks, mitigation plans, and timelines, enabling knowledge sharing of regulatory intelligence insights and risks across CPMQ.
• Ensure implementation of change control and actions completed to address new and revised regulations; oversee the review, completion, and closure of routine and complex, impactful strategic clinical-related change controls and pharmacovigilance-related change controls.
• Provide data insights to emerging regulations and requirements, operational and compliance metrics and storyboards, identify quality and compliance risks, and proactively provide strategic and tactical directions for 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 improvement projects. Represent and participate in improvement projects related to safety and clinical trial delivery in partnership with GDO, PSPV, and GRA; review outputs of the redesigned processes and coordinate CPMQ colleague input.
• Provide CPMQ insights on continuous improvement that are enterprise-wide (e.g., Veeva, QMS, Enterprise Audit) to Global Quality and R&D Quality; present status, insights, and impact of projects impacting clinical and safety quality at periodic intervals.
• Identify key areas for process improvements and develop, execute plans according to timelines; support implementation of new and revised processes across CPMQ.
• Contribute 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.

Qualifications

• BSc in a scientific, allied health, or medical field (or equivalent).
• Minimum of 7 years of increasing responsibility 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 and GCP/GVP regulations including FDA, EU, MHRA, PMDA, and ICH.
• Experience with development and implementation of a clinical or pharmacovigilance audit program, hosting or leading regulatory inspections, investigations, and remediation activities on a global level.
• Experience managing complex organizational compliance issues 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).
• Excellent communication skills and active listening, capable of conveying messages and building win‑win solutions.
• Exceptional critical thinking and problem‑solving ability to address challenges and advocate for solutions.
• Ability to succinctly translate and communicate complex issues.
• Fluency in English; additional language skills are a plus.

Compensation and Benefits

U.S. Base Salary Range: $153,600.00 – $241,340.00. Benefits include health, dental, vision, 401(k) match, short‑term and long‑term disability, life insurance, tuition reimbursement, paid volunteer time, company holidays, wellness benefits, up to 80 hours of sick time, and 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.