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Head Of Quality Control And As&T

Company

Novartis

Address , Morris Plains
Employment type FULL_TIME
Salary $144,000 - $216,000 a year
Expires 2023-12-07
Posted at 9 months ago
Job Description

365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.
This role is responsible for ensuring production operations, from raw materials to finished products, meet the quality, integrity, and efficiency standards set by the organization and in compliance with cGMP standards for Cell and Gene Therapy Products regulations for clinical and commercial globally distributed products.
The role is expected to proactively drive changes and improvements to all aspects of Quality Control including improved efficiency (i.e. Automation, Lean Six Sigma, etc.) while continuously enhancing a site quality culture of compliance through implementation of harmonized standards, testing, monitoring and reporting.
The organizational structure for this role includes a QC Raw Materials, QC Microbiology/Environmental, QC Analytics, and AS&T teams.

The incumbent is expected to demonstrate the following skills:
  • Process management and enhancement: Continuously look to identify opportunities to improve departmental processes and procedures to increase efficiency and effectiveness.
  • Communication skills: should also possess strong written and verbal communication skills to develop procedures and communicate across departments.
  • Financial management: Expected to deliver on increase efficiency and effectiveness of the department some basic financial management skills are needed.
  • Team leadership skills: effective team leadership is key in this role, since the director of quality manages teams of quality assurance personnel and directs their activities.
  • Problem-solving skills: effective problem-solving is also essential in this role and should be able to assess quality issues and develop functional solutions.
Scientific skills: have an understanding of analytical techniques, aseptic operations, and validation requirements.
Your responsibilities include, but are not limited to:
  • Collaborates with management and senior staff across production departments.
  • Evaluates production operations from a strategic level to ensure that products meet quality, industry, and business requirements.
  • Participate in the preparation and consolidation of the budget of the Quality Unit
  • Maintain the Quality Control laboratories in cGMP compliance and continue to challenge the status quo of the laboratory to enhance throughput efficiency, compliance, and testing platforms.
  • Engage in projects to assure cGMP beyond compliance and state of the art scientific approach to Cell and Gene Therapy Quality.
  • Lead the AS&T team responsible for strategy for the platform, including receiving of method from technical development and clients, validate and transfer into site, support stability program across the CGT Platform, method optimization & technology procurement for next generation QC assays and accountability for change controls.
  • Directs and oversees the quality control leadership team and department staff. Conducts continuous performance evaluations and development that are timely and constructive. Handles recognition and discipline of employees in accordance with company policy.
  • Leads the development, revision, application, maintenance, validation, and review of quality standards, documents, and methods for processing and/or ensuring quality in intermediates or finished products.
  • Ensures that laboratory scheduling, logistics, and flow of activities for testing and review are set and followed.
  • Ensure timely closure of investigations including: OOS, OOE, and deviations and implementation of appropriate CAPA.
  • Knowledge and familiarity of Quality Documentation systems
  • Ensure health & safety procedures are followed within the Laboratory.
  • Assure that all test methods and specifications compliant with current USP/NF.Knowledge and familiarity of SAP systems, including Quality Module (QM).
  • Periodically reports status of quality control and operations to executive leadership and, when required, regulatory agencies.
  • Prepare and participate in Health Authority inspections and internal audits.
  • Knowledge and familiarity of LIMS systems (Labware LIMS) and Trackwise
  • Accountable for raw material testing, in-process and final product analytical testing such as flow cytometry, ELISA, cell count, cell viability, sterility, endotoxin, and qPCR

EEO Statement

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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum requirements

  • Working Knowledge of USP, cGMP, and Regulations for the various health authorities
  • Minimum of 7 years’ experience in the pharmaceutical/biotechnology industries conducting QC testing, release testing and coordinating the activities of a QC laboratory
  • Minimum of a MS degree in biology, chemistry, biochemistry or other related science.
  • Demonstrated experience leading large multi levels teams required.
  • A minimum of 5 years with people management experience managing a large team with direct & indirect reports
  • Working knowledge of quality system requirements
Desirables:
  • Project management, Lean, Operational Excellence, Product/Process Development or Regulatory highly desirable
  • Cell and gene therapy experience is preferred.
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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!
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.The pay range for this position at commencement of employment is expected to be between $144,000 and $216,000 per year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Division

Operations

Business Unit

QUALITY

Country

USA

Work Location

Morris Plains, NJ

Company/Legal Entity

Novartis Pharmaceuticals

Functional Area

Quality

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No