Principal Quality Lead, Analytical & Stability Services
Job DescriptionJob TitlePrincipal Quality Lead, Analytical &
Stability ServicesCompanyEndo VenturesFunctionQualityLocation(s)Dublin, IrelandDepartmentAnalytical &
Stability ServicesDirect Reports (list)N/AReports to (title)Assoc Dir, Quality OperationsDate Submitted9/30/2019To be completed by Corporate Compensation:
Job CodeJ04495BandDDate Reviewed9/30/2019BenchmarkAQY000-P4-13EEO-FLSA (USA only)-Job Summary - a concise overview of the jobWith extensive experience and the ability to interpret regulations, guidances, and internal policies, the Principal Quality Lead, Analytical &
Stability Services provides high level expertise of cGMP requirements and applies them for the compliant execution of the most complex, full lifecycle drug development projects. Provides the required Quality &
Compliance direction during Product Development, Regulatory Filing, Approval and Commercial Transfer for pharmaceutical products. Drives the concepts and strategies for product understanding and robustness during product development. The end result being delivery of products that have expeditious regulatory approvals and are robust to manufacture.All incumbents are responsible for following applicable Division &
Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&
L responsibility, etc.Endo VenturesKey Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeQuality Assurance &
ComplianceProvides highlevel expertise of cGMP requirements, with ability to interpret regulations, guidance, and internal policies and apply them in context of compliant execution of the most complex full lifecycle drug development projects.
Recognizes problems proactively and develops options to solve complex problems.100%Analysis &
TestingLeads development and maintenance of QA Analytical programs, policies, processes, procedures and controls.
Leads the development and validation of analytical methods and the evaluation of compendia changes/updates.
Oversees project status to ensure that project timelines are met and the team works in compliance with cGMP, GLPs and all other applicable requirements.
Provides guidance to other staff in review and approval of GMP documents.InvestigationsLeads root cause identification of complex laboratory investigations, including identification and qualification of unknowns.
Apprises management of the status of investigations and works with Compliance to determine if any regulatory actions are to be taken.MetricsEstablishes a process of monitoring performance Quality metrics for Commercial Stability Program, identifies trends, and recommends improvements or potential market action.TrainingProvides coaching and development to more junior specialists, as appropriate.Total100%QualificationsEducation &
ExperienceMinimal acceptable level of education, work experience and certifications required for the jobBachelor?s degree in chemistry, chemical engineering or related field with a minimum of 9-13 years? relevant analytical laboratory experience OR
Master?s degree in above disciplines with a minimum of 7-11 years? relevant analytical lab experience OR
PhD with a minimum of 4-8 years? relevant pharmaceutical lab experience.
Must have prior experience in analytical methods development and validation.
Must have prior experience in stability management.KnowledgeProficiency in a body of information required for the job
E.G. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Strong knowledge of analytical chemistry (methods development, validation and specifications) and stability requirements.
Deep knowledge of all current state, federal, and local US and EU standards and regulations (ICH, EU GMPs, US CFRs, ISO, etc.).
Extensive knowledge of pharmaceutical dosage forms/devices, GMPs, FDA regs and guidance documents and how to apply them to product development process and technology transfer processes.
Thorough understanding of ICH guidelines.
Full proficiency with various laboratory techniques.
Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS.
Has demonstrated competence in conducting chemical analyses.Skills
AbilitiesOften referred to as ?competencies?, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.G. coaching, negotiation, calibration, technical writing etc.Extensive theoretical background and experience in analytical chemistry supporting all phases of drug development programs
Able to make quality assessment and conducting troubleshooting. Ability to conduct quality incident investigations (OOS, OOT, Deviations and Investigations)
Experienced in writing analytical development and validation reports.
Ability to review and approve analytical data and test methods. Ability to lead teams and supervise others
Must have excellent verbal and written communication skills and good organizational skills.
Action orientated. Attention to details and team player attitude.
Be a self-starter and able to manage multiple priorities in a fast paced environment.
Ability to work effectively across all levels within the organization to ensure priorities is completed while supporting the project teams.
Ability to use Word, Excel, Outlook, Access
? Proficient in writing and verbal communications with peers, supervision, and inter-departments.
Ability to lead projects and teams;
ability to supervise others.
Timely decision making
Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information
Ability to display and analyze data in a logical manner
Strong verbal and written communication skills as well as good computer skills.
Strong attention to details and accurate record keeping.
Solid organizational skills
Ability to coach less senior staff and develop laboratory skills and ability.
Ability to take initiative, set priorities and follow through on assignments.Physical RequirementsPhysical &
mental requirements e.G. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.Lift 15 lbs.
Walk across lab/plant/warehouse.
Ability to travel if needed.
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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