Planning Lead efforts to ensure that the site is audit/inspection ready, meeting commitment deadlines and CAPAs/action items are tracked and completed in accordance with respective project plans.
Lead projects and provide oversight to continually improve site compliance posture
Adherence to Internal Audit Schedule and External Audit Inspection Preparation
Adherence to new product and market extension project timelines for regulatory submissions, responses, and associated change controls
Adherence to master plan timelines and externally set commitments
Technical Perform compliance activities which ensure required quality and safety standards are being met for our products.
Perform compliance activities of complex nature as per schedule and per standards/SOPs.
Exhibit expertise on topics such as: GMPs, Risk Management, Change Control , Annual Product Review, Audit, Gap Assessment, Regulatory documentation (submissions, re-registrations, market extensions, responses), external standards and the Novartis Quality Manual
Maintain high level of integrity and motivation to ensure duties are executed in accordance with regulations and standards.
Show knowledge of cGMP regulations for pharmaceutical manufacturing operations and validation procedures and practices.
Possess understanding of the relationships between Manufacturing, Quality Control, Quality Assurance, Compliance, R & D and Regulatory Affairs.
Demonstrate excellent verbal and written communications and interpersonal skills
Appropriately allocate effort and priority among several goals and projects with a high degree of independence.
Employ sound judgment by evaluating problems thoroughly, soliciting input and ideas, and using a systematic decision making approach.
Effectively challenge the status quo and use knowledge and experience to continuously improve work processes.
Write and take ownership for compliance SOPs and systems and serve as peer review and approval of documentation
Review investigative testing to support laboratory investigations; participate in root cause analysis
Participate in self-inspection program as guest assessor or lead auditor
Team Lead and support peers to enhance overall capability of the organization.
Direct compliance initiatives/projects or programs using problem solving and strategic improvement methodologies (ie. Six Sigma)
Train/mentor team members
Demonstrate flexibility in work hours and conditions
Exhibit Novartis Values and Behaviors
Interfaces Coordinate/support other departments to ensure smooth execution of work.
Effective communication skills both verbal and written concerning compliance actions with other departments which may include affiliates, R&D, Regulatory Affairs, Global, and other manufacturing sites
Participate in global compliance initiatives as required
Coordinate and provide support to external audits and health authority/regulatory inspections
Safety/Housekeeping Keep work areas clean and free of hazards or dangerous conditions
Participate in site safety programs
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum: Bachelors of Science in Microbiology, Biology, Chemistry or any Engineering Discipline with at least 5 years direct experience in pharmaceutical manufacturing, Medical Device or related industry
Preferred: Bachelors of Science or Engineering plus Master s Degree in Regulatory Affairs or related discipline with at least 7+ years applicable experience in pharmaceutical manufacturing, Medical Device, or related industry with at least 4 years in Quality Assurance capacity
Must be fluent in English
Skills Profile:
Knowledge of external regulatory requirements and pharmacopeia (especially 21CFR210/211/820, EU GMP, USP, Ph EU, JPAL)
Proficient in technical writing and project planning/administration
Experience within regulatory affairs, authoring/approving ANDA/NDA/510K submissions and subsequent responses to regulatory bodies/ministry of health/Food and Drug Administration Problem solving, root cause identification
Effective Written and Verbal communication
Adherence to externally driven timelines and fixed
Demonstrated leadership and negotiation skills
Microsoft Office suite, Enterprise Quality management software (databases incl. SQL, Oracle, Informix
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considered, please do so. Applications for all positions are subject to each employer's specific requirements.
