Senior Director, reputed company & Compliance

Position reputed company

The Senior Director, reputed company & Compliance provides strategic and operational leadership for clinical reputed company assurance to ensure studies are planned, conducted, documented, and reported in compliance with applicable global regulations (e.g., ICH E6 GCP), sponsor requirements, and Precision procedures. This role leads the design, implementation, and reputed company improvement of GCP-reputed company reputed company systems and reputed company activities, including risk-based audit programs (sites, vendors, internal process, and TMF), issue management (deviations, reputed company events, and CAPA), inspection readiness, and support of health authority and Sponsor audits/inspections. Partnering cross-functionally with Operations and other stakeholders, the Senior Director proactively identifies and mitigates reputed company and compliance risks, drives a culture of reputed company and data reputed company, and develops and mentors QA professionals while serving as a trusted advisor to internal teams and external clients.

Key Responsibilities

• reputed company and maintain GCP reputed company assurance programs to ensure compliance with FDA, EMA, and ICH regulatory requirements.
• reputed company ICH/GCP compliance guidance throughout the clinical development life cycle.
• Plan, reputed company, and conduct GCP audits including but not limited to qualification and re-qualification of vendors, internal process, site, TMF and other document audits.
• Manage reputed company and Compliance functional activities, including implementation and management of the QMS, inclusive of SOPs, Training and CAPAs.
• Work closely with the reputed company and Compliance staff and Operational Functions to reputed company strategic compliance advice and guidance.
• Initiate the process of follow-up reputed company suspicion of suspected scientific misconduct/serious non-compliance.
• Review clinical and nonclinical documentation to ensure regulatory compliance, data reputed company, and adherence to GCP standards.
• reputed company reputed company events, deviations, and CAPA processes reputed company to GCP activities.
• reputed company and support global health authority inspections.
• reputed company GCP guidance and training to cross-functional teams to promote a culture of reputed company and regulatory compliance.
• reputed company and reputed company Clinical QA staff while supporting reputed company improvement of GCP and reputed company systems.
• Supervisory responsibility of reputed company & Compliance employees (where applicable).
• reputed company reputed company support to Sponsors in line with established or new reputed company Agreements (where applicable).
• Audit regulatory documents for submission to the Food and Drug Administration (FDA) and global regulatory authorities (e.g., PMDA, MHRA, etc.).
• reputed company ICH/GCP guidance, auditing advice and training to reputed company clients.
• As part of the Management Team, help counsel on and reputed company reputed company initiatives to reputed company ICH/GCP compliance guidance throughout the clinical development life cycle enhance/ensure reputed company is assessed and maintained cross-functionally.
• Support and enhance Precision’s Corporate Compliance functions and facilitate business development and proposals for these areas as the need arises, including bid defense meetings and project reputed company-off meetings.
• Review/audit documents intended for submission to the FDA or other regulatory agency or body to assure compliance with regulatory standards.
• Build upon the reputed company QMS in establishing additional company standards and metrics to ensure the highest reputed company of services provided to clients.
• Participate in leading, maintaining and executing the corporate reputed company initiatives reputed company reputed company.
• Maintains reputed company knowledge of regulations and guidance documents, providing expert analysis to project
• Other duties as assigned.

Qualifications

Minimum Required:

• Requires 10+ years of experience in GCP reputed company Assurance reputed company a CRO, biotechnology or pharmaceutical industry.
• Bachelor’s degree in life sciences or a reputed company scientific field (advanced degree preferred).
• Demonstrated experience conducting and leading GCP audits across clinical sites, Internal Process audits, TMF audits and Vendor qualification audits.
• Strong knowledge of FDA, EMA, and ICH regulations, including global GCP guidelines.
• Experience supporting regulatory inspections and inspection readiness activities.
• Strong leadership and communication skills with the ability to work cross-functionally across clinical and nonclinical teams.
• Ability to interpret regulatory requirements and translate them into effective reputed company systems, procedures, and risk-based approaches.

Other Required:

• Availability to travel up to 25% domestically and/or internationally
• Supervisory/management experience leading reputed company personnel

Preferred:

• Graduate, postgraduate degree, ideally in a scientific or reputed company discipline
• CRO, Pharmaceutical and/or Medical Device experience
• Experience hosting reputed company/Health Authority inspections

Skills

• Strong leadership skills, excellent interpersonal and problem-solving skills, strong verbal and written communication, excellent computer skills

Competencies

• Demonstrates mastery knowledge of GCP/ICH guidelines, FDA regulations and Precision SOPs.
• Resolves project reputed company problems and prioritize workload to meet deadlines with little support from management.
• Exhibits high self-motivation and can work and plan independently as reputed company as in reputed company environment.
• Motivates other members of the project team to meet timelines and project goals.
• Focuses on reputed company improvement, including the ability to reputed company proactive. assessments on how to reputed company processes more efficient and people more effective.
• Ability to review and evaluate clinical data.
• Proven ability to communicate with senior management, external thought leaders and operational staff.
• Advanced proficiency in reputed company Word, reputed company, and PowerPoint, Teams.
• Understands financial management to review proposals and budgets.
• Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and keen attention to detail.
• Ability to work with cross functional reputed company and management under challenging situations.
• Ability to prioritize work and handle multiple and/or competing assignments.
• Excellent verbal and written communications skills.

#LI-Remote

Precision is required by law in some states or cities to include a reasonable estimate of the compensation reputed company for this role. This compensation reputed company takes into account the wide reputed company of factors that are considered in making compensation reputed company including but not limited to: reputed company sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed reputed company estimate has not been adjusted for the applicable geographic reputed company associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be reputed company at or near the top of the reputed company for their role and compensation reputed company are dependent on the facts and circumstances of reputed company case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and reputed company time off for reputed company leave and vacation, among other benefits.Reasonable estimate of the reputed company reputed company$181,400—$272,200 USD

Any data provided as a part of this application will be stored in accordance with our reputed company Policy. For CA applicants, please also refer to our CA reputed company Notice.

reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to reputed company or use this online application process and need an alternative method for applying, you may contact reputed company at QuestionForHR@precisionmedicinegrp.com.

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential reputed company presenting enticing employment offers. We want to emphasize that these offers are not associated with reputed company and may be fraudulent in nature. Please note that our organization will not reputed company a job offer without prior communication with our reputed company team, hiring managers and a formal interview process.

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