Manager, Quality Control

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Manager, Quality Control Biochemistry will own all work processes associated with the Biochemistry laboratory including overseeing testing activities and ensuring compliance with respect to methods, protocols and procedures. This position will be the subject matter expert for Biochemistry related activities during regulatory inspections and the document owner for procedures in support of the Quality Control Programs. Responsibilities include, but are not limited to program management, technical writing, training, metrics, and investigations.

The Manager, Quality Control Biochemistry must have a strong understanding of analytical techniques, manufacturing operations, GMPs and the principles behind them and be an effective communicator with the ability to lead investigations and identify/implement CAPAs.

Responsibilities

• Provide departmental leadership through timely communication, effective decision-making, emotional intelligence and cultivation of relationships within the department and across the organization.
• Oversees testing activities and ensure that regulatory compliance, data integrity, quality control, and organizational standards with respect to sampling, methods, and procedures are met.
• Acts as a subject matter expert during regulatory inspections and as the document owner for procedures in support of the Quality Control ddPCR Laboratory.
• Collaborates with site functional teams including Manufacturing, Quality Assurance, Supply Chain, MS&T and others to achieve company objectives.
• Executes proper investigation into the root cause of material and/or process failures, and assists in determining appropriate material disposition and/or process improvements.
• Assists in ensuring 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
• Manages employee performance and supports interviewing and training of staff.
• Builds, develops and manages laboratory team and oversees associates regarding staffing needs, project management, training, professional growth, associate behavior, corrective action, succession planning, work scheduling, compensation administration and payroll submission.
• Other related duties as assigned.

Qualifications

• Bachelor's degree in Chemistry, Biology or related sciences
• 5 years of relevant experience in GMP testing laboratory with 2 years of supervisory experience
• Strong understanding of material sampling, analytical techniques, manufacturing operations, cGMPs and the principles behind them
• Ability to communicate effectively, lead investigations and identify/implement CAPAs
• Strong understanding of cGMP regulations
• Strong problem-solving abilities
• Good critical thinking, deductive reasoning, and decision-making skills
• 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 the organization

Approximately 10-15% travel required.

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

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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