In this regard supports the gap assessment process and respective remediation and action tracking ... Build fit for purpose aseptic governance and training program in collaboration with engineering and ...
In this regard supports the gap assessment process and respective remediation and action tracking ... Build fit for purpose aseptic governance and training program in collaboration with engineering and ...
... remediation programs, laboratory systems, and cleaning validation initiatives. Why This Project ... High-visibility project with direct client interaction * Blend of Cleaning Validation and Data ...
Quick apply
... remediation programs, laboratory systems, and cleaning validation initiatives. Why This Project ... High-visibility project with direct client interaction * Blend of Cleaning Validation and Data ...
... remediation programs, laboratory systems, and cleaning validation initiatives. Why This Project ... High-visibility project with direct client interaction * Blend of Cleaning Validation and Data ...
Quick apply
... remediation programs, laboratory systems, and cleaning validation initiatives. Why This Project ... High-visibility project with direct client interaction * Blend of Cleaning Validation and Data ...
Demonstrated success leading directors, senior managers, architects, and security engineering teams ... Vulnerability management programs * Red teaming exercises * Bug bounty and responsible disclosure ...
Demonstrated success leading directors, senior managers, architects, and security engineering teams ... Vulnerability management programs * Red teaming exercises * Bug bounty and responsible disclosure ...
... direct impact on the success and growth of our organization. In this role, you'll manage projects ... Manage demolition and environmental remediation projects from award through closeout. * Develop ...
Quick apply
... direct impact on the success and growth of our organization. In this role, you'll manage projects ... Manage demolition and environmental remediation projects from award through closeout. * Develop ...
... direct impact on the success and growth of our organization. In this role, you'll manage projects ... Manage demolition and environmental remediation projects from award through closeout. * Develop ...
... direct impact on the success and growth of our organization. In this role, you'll manage projects ... Manage demolition and environmental remediation projects from award through closeout. * Develop ...
Manager, Information Security
Raleigh, NC · On-site
... security program. Why Jewelers Mutual Since 1913 we've been committed to supporting the Jewelry ... Oversee vulnerability management operations, including scanning cadence, remediation service-level ...
Manager, Information Security
Raleigh, NC · On-site
... security program. Why Jewelers Mutual Since 1913 we've been committed to supporting the Jewelry ... Oversee vulnerability management operations, including scanning cadence, remediation service-level ...
Manager, Information Security
Raleigh, NC · On-site
... security program. Why Jewelers Mutual Since 1913 we've been committed to supporting the Jewelry ... Oversee vulnerability management operations, including scanning cadence, remediation service-level ...
Manager, Information Security
Raleigh, NC · On-site
... security program. Why Jewelers Mutual Since 1913 we've been committed to supporting the Jewelry ... Oversee vulnerability management operations, including scanning cadence, remediation service-level ...
Manager, Information Security
Raleigh, NC · On-site
... security program. Why Jewelers Mutual Since 1913 we've been committed to supporting the Jewelry ... Oversee vulnerability management operations, including scanning cadence, remediation ...
Manager, Information Security
Raleigh, NC · On-site
... security program. Why Jewelers Mutual Since 1913 we've been committed to supporting the Jewelry ... Oversee vulnerability management operations, including scanning cadence, remediation ...
... direct impact on the success and growth of our organization. In this role, you'll manage projects ... Manage demolition and environmental remediation projects from award through closeout. * Develop ...
... direct impact on the success and growth of our organization. In this role, you'll manage projects ... Manage demolition and environmental remediation projects from award through closeout. * Develop ...
... assessment, remediation, and risk-based cleanup * Experience navigating regulatory programs in ... Direct access to leadership and visibility across the organization * Opportunities to influence ...
... assessment, remediation, and risk-based cleanup * Experience navigating regulatory programs in ... Direct access to leadership and visibility across the organization * Opportunities to influence ...
... assessment, remediation, and risk-based cleanup * Experience navigating regulatory programs in ... Direct access to leadership and visibility across the organization * Opportunities to influence ...
... assessment, remediation, and risk-based cleanup * Experience navigating regulatory programs in ... Direct access to leadership and visibility across the organization * Opportunities to influence ...
... assessment, remediation, and risk-based cleanup * Experience navigating regulatory programs in ... Direct access to leadership and visibility across the organization * Opportunities to influence ...
Quick apply
... assessment, remediation, and risk-based cleanup * Experience navigating regulatory programs in ... Direct access to leadership and visibility across the organization * Opportunities to influence ...
Support and manage environmental assessment and remediation projects locally and nationally, both ... Learn to navigate state and federal environmental regulatory programs in North and South Carolina
Support and manage environmental assessment and remediation projects locally and nationally, both ... Learn to navigate state and federal environmental regulatory programs in North and South Carolina
Manager Security Compliance and Risk Management
Raleigh, NC · On-site
$118K - $219K/yr
This role owns the frameworks, processes, and programs that provide structured oversight of ... Ensure findings and remediation activities are tracked and managed to resolution within required ...
Manager Security Compliance and Risk Management
Raleigh, NC · On-site
$118K - $219K/yr
This role owns the frameworks, processes, and programs that provide structured oversight of ... Ensure findings and remediation activities are tracked and managed to resolution within required ...
Support and manage environmental assessment and remediation projects locally and nationally, both ... Learn to navigate state and federal environmental regulatory programs in North and South Carolina
Quick apply
Support and manage environmental assessment and remediation projects locally and nationally, both ... Learn to navigate state and federal environmental regulatory programs in North and South Carolina
Support and manage environmental assessment and remediation projects locally and nationally, both ... Learn to navigate state and federal environmental regulatory programs in North and South Carolina
Support and manage environmental assessment and remediation projects locally and nationally, both ... Learn to navigate state and federal environmental regulatory programs in North and South Carolina
Program Director Remediation information
See Raleigh, NC salary details
$28.7K - $38.2K
5% of jobs
$38.2K - $47.7K
13% of jobs
$51.2K is the 25th percentile. Wages below this are outliers.
$47.7K - $57.2K
19% of jobs
The median wage is $65.7K / yr.
$57.2K - $66.7K
15% of jobs
$66.7K - $76.2K
11% of jobs
$85.1K is the 75th percentile. Wages above this are outliers.
$76.2K - $85.7K
14% of jobs
$85.7K - $95.2K
9% of jobs
$95.2K - $104.7K
5% of jobs
$104.7K - $114.2K
2% of jobs
$114.2K - $123.7K
2% of jobs
$123.7K - $133.2K
5% of jobs
$28.7K
$76K
$133.2K
How much do program director remediation jobs pay per year?
Director, Global Sterility Assurance Team Lead
Durham, NC • On-site
Full-time
Medical, Retirement, PTO
Re-posted 5 days ago
Key responsibilities
Lead a team of experts in aseptic processing across manufacturing sites and ensure compliance with FDA and other health authority inspections.
Support and oversee the implementation of projects related to GMP updates, aseptic process optimization, and site readiness for inspections.
Own and monitor sterility assurance activities, develop improvement plans, and build aseptic governance and training programs.
Novartis rating
7.8
Based on 18 frontline employees who took The Breakroom Quiz
Job description
Job Description Summary
As Director, Global Sterility Assurance Team Lead you will:• Lead a team (4-6 direct reports, 20-30 indirect) of Key functional Expert for Aseptic processing within the Novartis manufacturing network (includes Large Molecules and Advance therapies and third parties producing for Novartis).
• Ensures and verifies that all actions related to FDA and other health authority inspections are understood and implemented by the sites in the platform, avoiding re-occurrence of 483’s and Warning Letters.
• Assure that key projects are implemented in the manufacturing sites as per committed plan to FDA and other health authorities
• Ensure implementation of changes to support GMP updates (i.e. Annex 1) within all the sites in scope in order to assure ongoing compliance for the upcoming years. In this regard supports the gap assessment process and respective remediation and action tracking.
• Liaise with TechOps to ensure implementation, follow up and completeness of all related Quality/ Compliance programs, documentation and Quality reporting of Aseptic related projects / metrics.
• Ensure adequate Health Authority Inspection preparation of the Sites in scope and successful inspection outcomes. Interactions with sites mainly require interpretation of complex information and persuasion both internally with other areas of the business and the site leadership team and externally.
Job Description
Major Accountabilities:
- Overall team leader that has the responsibility of 4-6 individual contributors hosted in US, Spain and Austria, plus 20-30 indirect reports located within the manufacturing sites performing sterile operations.
- Lead cross site/platform and network projects and harmonization initiatives as assigned
- Provide expert advice and appropriate technical support to ensure site readiness for Health Authority and GGA inspections by supporting sites in their preparation, up to and including hands on preparation of materials (i.e. storyboards for complex cases, etc.)
- Primary Responsible for optimization of aseptic processes (as e.g. cleaning and disinfection programs, microbiological monitoring and sterilization techniques) between sites and platforms within the Novartis manufacturing network
- Support escalations for specific topics (i.e. Microbial contaminations, sterility issues, etc.) with the manufacturing sites if needed, and in collaboration with the other members of the platform (i.e. QA operations, QA compliance lead, QC/AS&T lead)
- Own, Monitor and act as Primary contact for the sterility assurance from the sites and define improvement plans as appropriate.
- Build fit for purpose aseptic governance and training program in collaboration with engineering and MS&T to support sites in development, training and understanding of aseptic topics
- Provides input for the selection, training, people development and performance evaluation, development planning and participating in recruiting process of the Aseptic experts within the manufacturing sites / global functions.
Obligatory requirements:
- Education: Graduate in Chemistry, Pharmacy, Microbiology or another related science; desirable: Ph.D. in science or related discipline
- 12 - 15 years experience in management and leadership roles in the pharmaceutical industry, preferably in a FDA-regulated environment and in QA Operations & Compliance of a strategic Site or a global role. Pharma production experience indispensable. Quality Assurance / cGMP regulations in USA, EU (Self Inspections, Auditing of 3rd parties, Complaint/Deviation Handling, GMP-Training, SOP-Systems).
- Deep understanding of microbiology and aseptic processes
- Solid People Management / Communication skills (To explain difficult business processes and related GMP-requirements to a community of very diversely oriented and educated people from a multitude of different units.
- Excellent Project Management skills, especially with crossfunctional projects.
- Fluent English written and spoken.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
You will receive: Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 27 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Skills Desired
About Novartis HEOR Fellowship Program
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing and pharmaceutical product wholesalers
Company size
10,000+ Employees
Headquarters location
East Hanover, NJ, US