Senior Specialist, GMP Cleaning Compliance

Location
Durham, NC, US
Posted
Jun 12, 2021
Ref
6090
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 Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

The Senior Specialist, GMP Cleaning Compliance, develops, organizes, and executes the implementation of the Critical Environment Cleaning Program across the business.

Responsibilities
  • Participates in internal and external strategy and planning meetings, surveys, new business presentations, mobilization, and support activities related to the Critical Environment Cleaning Program.
  • First line of contact to all facilities cleaning , GMP & Non- GMP cleaning.
  • Ensure site cleaning and gowning programs in compliance with Novartis Standards to maintain site in compliant state for GMP manufacturing of gene therapy products.
  • Develops and maintains compliant housekeeping program to ensure GMP manufacturing and testing facility is in compliant inspection ready state. Programs to include routine walkthrough of GMP warehouse, manufacturing and test labs, to identify, track and resolve housekeeping deficiencies.
  • Manages budget and staffing levels to ensure appropriate resources available for both FTE and external service providers.
  • Approves vendor invoices as needed and assist in developing and approving necessary service contracts.
  • Manages inventory levels for both cleaning and gowning materials as well as supplier contracts or service contracts associated.
  • Reviews and evaluates existing cleaning programs, services, makes recommendations to operations team and/or client.
  • Maintains compliant procedures and logbooks associated with activities.
  • Leads investigations related to cleaning, gowning or housekeeping.
  • Authors deviations, non-conformances, and CAPAs.
  • Partners with Quality to address these issues effectively and compliantly.
  • Coordinates daily operations with scheduling team to ensure cleaning activities align with manufacture and testing operations.
  • Develops and reports appropriate KPI for cleaning, gowning and housekeeping.
  • Identifies and implements continuous improvement opportunities.
  • Leads and mentor staff.
  • Writes performance reviews and annual goals, holds one-on-ones, and handle HR related matters Implement, train and educate staff on the on-going efficient delivery, operation and maintenance of the cleaning program.
  • Other related job duties as assigned.

Qualifications
  • Bachelors' Degree in biochemistry, chemical engineering, bioengineering or related technical field with 5 years of experience in biopharmaceutical industry or 9 years relevant industry experience in lieu of degree.
  • Solid knowledge of FDA regulations and GMP systems.
  • Excellent oral and written communication skills.
  • Strong technical writing ability.
  • Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence.
  • Demonstrated leadership skills.
  • Project management skill set with experience in strategic/tactical planning, team building, and meeting budgets.
  • Experience managing contract employees or service providers in GMP environment.
  • Experience and working knowledge of GxP, and ISO safety cleaning standards.
  • The ability to read, comprehend, and transmit complicated detailed instructions in writing and orally required.
  • Possess a thorough knowledge of contract administration and office procedures.
  • Ability to write reports, business correspondence, and procedure playbooks and manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
  • Working knowledge of principles and practices business administration, procurement, contracts, financial principles and practices.
  • Knowledge of the Business and Industry marketplace, current Good Manufacturing Practice (cGMP) and other critical environment cleaning practices and procedures, applicable laws, health, safety and environmental practices, principles of management and supervision, and department procedures and policies.


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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