Manager, QA/Compliance

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Think What's Possible.Position Description:
Manage, support and coordinate compliance Strategic plans in NA for added brands growth. As a member of new Licensing Team, support new product launch, PAI inspections, Due diligence visits, QA R&D investigations, R&D stability, SOPs, validation protocol /reports, initial audit assessments, and GMP training. Transfer new validated products from R&D group to production sites.
Support Product Development, analytical R&D, operation, technical services, and product/process improvements at contract facilities. Establish and implement quality and compliance requirements for new product launch. Establish priorities based on team priorities. Provide communication and process linkage with Project teams, Operation, Research & Development, Third Party Contractors, Technical Services and Regulatory, internally and externally. Improve systems, eliminate barriers, and investigate quality issues using applicable process improvement and problem- solving techniques.
Coordinate team modules, behavior competencies, strategic thinking and leadership skills, process capability and problem-solving skills. Implement team strategic plan and objectives.
Utilize active thinking to generate creative solutions to complex quality and production technical problems stemming from investigations and computer/instrument/equipment or process failures. Facilitate and support required documentation to meet the regulations, appropriate follow-up and implementation of preventative actions.
Liaison between R&D and Product Supply
OTC Project Team Member
Clinical Supplies Release
Assist in Product Transfer to Commercial QA/QC
Due Diligence visits for new suppliers, manufacturers and laboratories used for developmental projects
Conduct audit to prepare for FDA PAI and assist with product supply audits
Write/implement R&D QA SOPs
R&D Stability Evaluation
Routine GMP audit of R&D facilities
Review CMC sections for regulatory submissions
Write QAA in conjunction with QA site for new product to be launched
Review and approve new raw material specifications
Write/ Approve developmental investigations
Assure completion of required validation Program with Technical Services and R&D
Establish, approve specifications, methods, procedures, investigations, validation and stability protocol/reports, other Quality Assurance / Control reports according to established procedures, GMPs, applicable regulations and team competencies.

Qualifications
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Degree in natural Sciences or related experience
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Minimum 8-12 years experience in Pharmaceutical, or Quality Auditing/GMP Regulatory Compliance
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Understanding of Quality systems and regulatory (GXPs) requirements, including auditing/ inspecting against regulatory/quality standards
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Strong communication and negotiation skills
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Understanding of the R&D development process and basic grasp of production requirements
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Good interpersonal and leadership skills
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Working knowledge of drug development process and GxPs
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Knowledge of relevant IT systems
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Good organizational skills
Normal office environment. Exposure to laboratories/manufacturing/packaging areas when visiting contractors.
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Traveling up to 60%

This position requires a broad knowledge of the processes involved in achieving a successful total quality assurance system. The incumbent must understand the definitions and boundaries of responsibilities for management, technical personnel and quality assurance groups. It is important that the QA systems are positioned appropriately so that optimal effectiveness can be maintained through their interactions with the audited areas and management. Incumbent must be able to design sufficient mechanisms to empower each group to define, maintain and continuously improve their internal quality systems. The incumbent must have the requisite QA expertise as well as Leadership, Competence, and Communication skills to assure that the total quality goals will be accomplished


Novartis is committed to embracing and leveraging diverse backgrounds.
Novartis is an equal opportunity employer M/F/D/V.

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