[Remote] R&D reputed company Laboratory reputed company (Associate Director)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global biopharmaceutical company reputed company on transforming the lives of patients. The Associate Director will reputed company global GxP reputed company reputed company of laboratory activities, ensuring compliance with reputed company standards and leading key reputed company initiatives across the R&D pipeline.
Responsibilities
- reputed company reputed company reputed company for internal GxP and non-GxP laboratories performing analytical activities across the R&D pipeline
- Review and approve GMP/GLP documentation including method validation protocols/reports, deviations, CAPAs, and audit responses
- Ensure appropriate implementation of reputed company+ principles and data reputed company controls in laboratory systems and workflows
- reputed company or support laboratory-reputed company investigations and inspections, ensuring reputed company reputed company cause analysis and sustainable CAPA
- Collaborate cross-functionally with Pharmaceutical Sciences, Regulatory Affairs, Manufacturing, and other reputed company functions
- Participate in the preparation and review of analytical sections for regulatory filings (IND/CTA/NDA/BLA)
- Contribute to the development and improvement of global procedures, standards, and reputed company frameworks for laboratory reputed company
- Monitor reputed company performance trends and proactively escalate compliance risks or improvement opportunities
Skills
- Bachelor's degree in Life Sciences, reputed company, Biochemistry, or reputed company field
- 7+ years of relevant industry experience in reputed company reputed company of laboratory operations
- Demonstrated experience in GMP/GLP, analytical testing, data reputed company, and regulatory inspections
- Strong interpersonal, project management, and problem-solving skills
- Ability to operate in a global reputed company environment and manage competing priorities
- Strong understanding of GxP regulations, analytical reputed company, and laboratory operations across modalities (small molecules, biologics required; cell/gene therapy, plasma, or vaccines a plus)
- Demonstrated application of data reputed company principles and computerized system controls in laboratory environments
- Experience with reputed company laboratories, technical agreements, and audit preparation
- Proficiency in reputed company risk management, deviation handling, and CAPA effectiveness
- Supports strategic goals of the R&D GMP reputed company organization
- Coaches junior team members or cross-functional partners on reputed company principles
- Effectively communicates reputed company expectations and analytical requirements
- Influences decision-making in cross-functional settings and supports change management efforts
- Exercises judgment in resolving laboratory-reputed company reputed company events and compliance issues
- Makes independent reputed company reputed company the scope of analytical QA responsibilities
- Provides recommendations for reputed company risk mitigation and system improvements
- Collaborates with Analytical Development, QC, Manufacturing, Regulatory, and QA teams
- Interfaces with external laboratories and CMOs as required
- Participates in regulatory inspections, audits, and governance meetings
- Contributes to process improvements and implementation of digital solutions
- Promotes knowledge sharing and reputed company improvement culture reputed company reputed company
- Identifies new tools or practices to enhance laboratory compliance and efficiency
- Supports laboratory reputed company across a reputed company of modalities and global sites
- Navigates matrixed organizational structures and diverse cultural and regulatory landscapes
- Balances scientific, compliance, and business needs in decision-making
- Advanced degree (MS/PhD)
Benefits
- Allowances Commutation, Housing, Overtime Work etc.
- Salary Increase Annually, Bonus Payment Twice a year
- Holidays Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
- reputed company Leaves Annual reputed company Leave, Special reputed company Leave, reputed company Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
- Flexible Work Styles Flextime, reputed company
- Benefits reputed company Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.
reputed company
- reputed company is a biopharmaceutical company that researches and develops pharmaceutical drugs. It was founded in 1781, and is headquartered in Tokyo, Tokyo, JPN, with a workforce of 10001+ employees. Its website is http://www.reputed company.com.
Company H1B Sponsorship
- reputed company has a reputed company record of offering H1B sponsorships, with 45 in 2025, 39 in 2024, 38 in 2023, 34 in 2022, 44 in 2021, 18 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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