Senior Manager, Qualification

Location
Durham, NC, US
Posted
Jun 30, 2021
Ref
6155
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

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 Senior Manager, Qualification is a subject matter expert in the commissioning and qualification program and provides leadership to manage the site qualification of equipment/instruments, utilities and computer systems.

Responsibilities

 

  • Manages site qualification master plan and deliverables.
  • Ensures compliance with all qualification standards.
  • Subject matter expert (SME) at site to support internal and/or external inspections.
  • Drives pro-active site inspection readiness programs and promotes quality and compliance culture.
  • Manages qualification team to support site qualification priorities and activities.
  • Manages the qualification team budget and supports site cost improvement initiatives.
  • Coaches, develops, and grows talent of team.
  • Hires and manages commissioning and qualification contractors to perform tasks.
  • Develops project execution plans and manages small to medium size projects.
  • Develops risk-based qualification approach and strategy (FMEA, PHA, etc.).
  • Supports development of commissioning and qualification policies and procedures to enhance the company's ability to conform to and maintain compliance with site, corporate and regulatory standards.
  • Manages and develops a tailored approach for each project they are assigned including; assessing vendor qualification packages, performing gap analysis to user requirements, developing plans, and protocols using a risk-based approach that comply with company policies and procedures.
  • Manages site qualification activities to support capital project, and quality and compliance driven initiatives.
  • Reports on project(s) progress and any roadblocks to the project team(s).
  • Performs risk assessments to confirm safe and compliant designs and recommend additional controls.
  • Manages Computer System Qualification.
  • Reviews project documentation (URS, FRS, Technical Specifications, Functional Specifications).
  • Liaise with client end user groups to ensure correct specification of equipment and utilities.
  • Authors and/or manages authoring of commissioning, qualification and qualification plans, qualification protocols, qualification summary reports and requirement trace matrices.
  • Participates in discussions with internal business partners on priorities, timelines and transparent sharing of information.
  • Partners with quality to ensure a quality and compliant manufacturing environment.
  • Manages site periodic review program and ensure validated state is maintained.
  • Other related duties as assigned.


Qualifications

 

 

  • Bachelor's degree in Engineering, Science or related technical field.
  • Excellent technical writing and verbal communication skills.
  • 8 years' experience in biotechnology GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish.
  • 8 years of experience in the design or operation of commercial grade pharmaceutical or biotechnology process equipment and utilities (compressed gas, hoods and cold storage).
  • 3 years management experience.
  • Must be people oriented and a team player.
  • In-depth knowledge of FDA regulations particularly 21 CFR part 11, 210, 211.
  • Working knowledge of ICH Q8, Q9, Q10 and other international regulatory requirements.
  • Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Visio.
  • Experience managing 3rd parties (both in-sourcing and outsourcing).
  • Ability to prepare contingency plans and logically work through complex issues in a high-pressure situation.
  • Approximately 10 - 20% travel.

 


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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