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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Product Quality Lifecycle Management, including Technical Risk Assessments and Change Control, while ensuring compliance with Drug and Food GMPs and global regulatory requirements. Proven ability to lead technical strategies, drive continuous improvement, and provide technical leadership in complex investigations and product quality assurance.
Highest-signal resume keywords
Product Quality Lifecycle ManagementTechnical Risk AssessmentsChange ControlDrug and Food GMPsFDA Regulatory Requirements
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Technical Strategy DevelopmentQuality Events ManagementDeviation ManagementCAPA ManagementAnalytical TestingFormulation DevelopmentManufacturing ProcessesRisk AssessmentTechnology TransferData Analysis
Soft Skills
LeadershipCollaborationTrainingCommunicationProblem-Solving
Tools & Technologies
SOPsBatch DocumentationManufacturing ProtocolsProduct SpecificationsQuality by Design Principles
Certifications & Qualifications
PMPAgileProgram ManagementPortfolio Management
Industry Keywords
Consumer HealthcareOral HealthGlobal Regulatory ComplianceICH GuidelinesManufacturing Sites
Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- Lead and own the global technical strategy for a product or product family
- Ensure consistent quality and robustness across all manufacturing sites
- Apply Product Quality Lifecycle Management, including current Technical Risk Assessments and Product Control Strategies
- Establish data-driven continuous improvement programs for quality, cost and efficiency improvements
- Analyze manufacturing, analytical and stability performance trends, escalate significant findings to the TRB, and recommend improvements
- Assess and manage post-approval changes while maintaining product quality and appropriate change controls
- Provide technical leadership for root cause analyses, complex investigations, product complaints and deviations with QA and sites/CMOs
- Assess new raw material suppliers and collaborate with Material Science and Procurement teams
- Provide technical justification to Health Authorities for global brands when required
- Ensure team work follows written quality and safety procedures, methods and batch documents
- Produce, contribute to or approve quality documentation, including SOPs, batch documentation, manufacturing protocols, reports, product specifications and development reports
- Provide technical leadership during technology transfer from R&D into Supply Chain and to other sites, applying Quality by Design principles
- Advise and train site product owners and key stakeholders on product knowledge and Product Control Strategies
Requirements
What you’ll need- Bachelor’s degree in Science, Engineering, Pharmacy or related science discipline
- 10 years of technical experience in consumer products
- Experience with Product Lifecycle Management activities, including Quality Events, Change Control, Deviation, CAPAs, trial and validation reports, and risk assessments
- Understanding of the auditing world
- Good knowledge of product manufacturing processes, including unit operations, device/packaging processes, plant equipment and analytical testing
- Previous experience developing conventional and potentially novel formulation dosage forms
- Thorough understanding of Drug and Food GMPs
- Familiarity with FDA, European and global regulatory requirements, such as ICH
- Excellent understanding of scientific and commercial aspects of the Consumer Healthcare industry
- Master’s or PhD preferred
- PMP, Agile, Program Management or Portfolio Management certifications preferred
- Previous Oral Health category experience preferred
- Proficient in Medical Device regulation knowledge relevant to project delivery preferred
- Site experience highly desired
- Operational experience with the ability to ideate and execute technical changes that drive growth and productivity
- Must be able to work on-site in Warren, NJ 3 days per week
Benefits
Comp & perks- 18% annual target bonus
- 401(k) plan
- Tuition reimbursement
- Time off programs
- 6 months paid parental leave
- Healthcare programs with the company paying for the majority of medical coverage for the employee and family
- Discretionary bonus based on key business performance
- Other incentive and recognition programs
- Hybrid work arrangement
