Manager or Senior Manager, Incoming Quality Control

Overview

Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives.

This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapy are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich's Ataxia.

Imagine the lives you could transform by joining the Novartis Gene Therapy team.

The Manager or Senior Manager, Incoming Quality serves as the owner for all work processes associated with the sampling and testing of incoming raw materials. This position oversees testing activities and ensures compliance with respect to sampling, methods, and procedures. Acts as a subject matter expert for Incoming Quality-related activities during regulatory inspections and as the document owner for procedures in support of the Quality Control Raw Material Programs. Responsibilities include, but are not limited to program management, technical writing, training, metrics, and investigations. A potential candidate will possess a strong understanding of material sampling, analytical techniques, manufacturing operations, GMPs and the principles behind them. The individual must be able to communicate effectively, lead investigations and identify/implement CAPAs.

Responsibilities

• Coordinates and performs timely, accurate and cGMP compliant testing of incoming raw materials.
• Participates effectively with site functional teams including Manufacturing, Quality Assurance, Supply Chain and MS&T to achieve company objectives.
• Determines appropriate analytical confirmatory testing of raw materials.
• Ensures alignment with current relevant monographs.
• Executes the guidelines to ensure the company has a robust raw materials program.
• Executes proper investigation into the root cause of material and/or process failures and assists in determining appropriate material disposition and/or process improvements.
• Ensures that internal and external laboratories comply with cGMP standards.
• Collaborates with Quality, MS&T and/or outside contract labs to ensure seamless method qualification/validation and transfer.
• Identifies and qualifies lab equipment.
• Reviews and approves raw material qualification and testing documentation.
• Supports interviewing and training of employees.

Qualifications

• Bachelor's degree in Chemistry, Biology or related sciences.
• Manager: 5 years of relevant experience in GMP testing laboratory with 2 years of supervisory experience. Senior Manager: 8 years of experience in pharmaceutical testing laboratory with 3 years of direct supervisory experience.
• Must have a demonstrated successful track record of directly supervising employees
• Strong understanding of cGMP regulations.
• Strong understanding of compendial and non-compendial raw materials analytical testing and associated instrumentation used to perform raw material testing.
• Strong problem-solving abilities.
• Good critical thinking, deductive reasoning, and decision-making skills.
• Deep experience with methods development and validation.
• Ability to work independently and effectively, prioritizing and delivering on tight timelines.
• Ability to work effectively within the site and across 3rd party testing laboratories.

The level of this position will be based on the final candidate's qualifications.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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