Quality Manager jobs in Hialeah, FL
Recently Added Quality Manager jobs
Quality - Trial Supplies Manager
- Eclaro
-
No Name Key, FL
FULL_TIME
-
Trial Supplies Manager
Job Number: (phone number removed)
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Trial Supplies Manager for our client in FL.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4.
The individual must partner closely with clinical, regulatory, quality and production associates to ensure timely delivery of supplies to study participants.
Responsibilities:
Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO’s, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
Working with teams for optimal use of the investigational material supply chain to achieve study and corporate goals.
Identifying and supporting strategies for continuous improvement and departmental and/or inter-departmental projects.
Co-creating clinical and development timelines and directly responsible for communicating timelines and investigational product strategies to Study Teams as well as cross-functional teams.
Proactively defining, planning, and communicating clinical supply strategy in support of global clinical studies, as well as monitoring and reacting to unforeseen clinical demand changes.
Developing supply forecasts through evaluation of the clinical development plan and protocol analysis.
Reviewing and providing input for draft medical protocols to develop packaging and labelling configurations and create packaging specifications in collaboration with Clinical Operations partners.
Collaborating with Global Clinical Supply Chain functions and external Vendors on the package design and label development for investigational product to meet all protocol and regulatory requirements.
Monitoring long-term inventory and allocation strategies considering drug recertification, country specific regulatory requirements, international drug shipment and overall demand.
Performing analytical assessments of drug utilization as it pertains to current forecasts versus inventories and creating product orders as needed.
Working with third party vendors to ensure the timely, efficient, high quality, cost effective execution of all outsourced clinical supply activities.
Ensuring releasable supplies for all assigned compounds and Protocols considering country Regulatory and QP Release documentation and requirements.
Initiating, reviewing and approving IRT specifications. Participating in user acceptance testing.
Developing investigational product distribution strategies maintaining distribution and supply strategy at depot and site level according to study (and IRT) requirements.
Actively participating in Trial Supplies Management Functional team, Study Team, Country Medical Affairs Affiliate & CSC Matrix Team Meetings providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation required.
Actively supports the CSC Budget Process.
Acting as the main Clinical Supplies contact person for the assigned Compound and associated studies, lead communications regarding global supply strategy with Study Team or Country Affiliate Medical Affairs team as appropriate.
Proactively identifying strategic and operational issues and develop proposals outlining solutions.
Managing conflicts / issues with internal and external partners and customers.
Demonstrating strong knowledge when presenting clinical supply processes at cross-functional meetings and actively participates.
Ability to coach new Trial Supply Managers on individual tasks.
Participating in training efforts for external functions on clinical supply processes to facilitate improved cross-functional relationships.
Traveling as required (<10%).
Writing of / input to departmental SOPs.
Performs other tasks as assigned.
Required Skills:
Moderate / Strong knowledge of the global drug development process and global regulatory requirements.
Proficient and strong analytical skills.
Strong communication and negotiation skills.
Proficient and strong Project management skills.
Strong knowledge of Forecasting and Planning and proficient knowledge of related areas, i.e. Manufacturing, Packaging & Labelling, IRT, Logistics, Quality, Stability, etc.
Proficient knowledge of import / export requirements.
Proficient/Strong knowledge of IRT and CTMS systems.
Proficient / Strong knowledge of industry technology.
Applies and drives Forecasting and Planning activity as it relates to protocol.
Ability to build/drive internal team consensus.
Translates broad strategies into specific objectives and action plans.
Team and individual leadership (lead courageously).
Oral and written communication (fosters open communication).
Conflict resolution (manages disagreements).
Negotiation (Manages Execution, Results Driven, Analysis of Issues, Effective Speaking, Builds Relationships).
Qualifications:
Coaching and mentoring (fosters teamwork).
Bachelor’s degree required.
2 years of relevant work experience required, preferably in a clinical supply environment.
An equivalent combination of education and experience may substitute.
As a key partner to many functions within the clinical supply chain and the broader research and development business this opportunity provides access to a wealth of learning and development possibilities within the pharmaceutical business.
If hired, you will enjoy the following Eclaro Benefits:
401k Retirement Savings Plan administered by Merrill Lynch
Commuter Check Pretax Commuter Benefits
Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Chris Imbien
(phone number removed)
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. - 11 Days Ago
Bilingual Quality Manager
- Springs Window Fashions
-
Hialeah, FL
OTHER
- Description Job Purpose: This position reporting to the VP of Quality, provide leadership organization’s performance-excellence, VOC, and process improvement efforts using quality management principle...
- 12 Days Ago
Training & Quality Assurance Manager
- Crystal Cruises
-
Aventura, FL
FULL_TIME
- Job Summary As a Training & Quality Assurance Manager, you will be responsible for facilitating the training needs of Reservations Global new hires, conducting recurrent training and webinars, as well...
- 15 Days Ago
Quality Control Assistant
- QUALITY AIRCRAFT PARTS
-
Miami, FL
FULL_TIME
- Quality Aircraft Parts has an immediate opening for an Quality Control Assistant. This is a full-time position, reporting to the Director of Quality Control.A & P Licenses are required.We are convenie...
- 4 Days Ago
Quality Assurance Supervisor/Manager - F-5 Aircraft Maintenance - NAS Key West,
- Vertex Aerospace LLC
-
Key West, FL
FULL_TIME
- DescriptionThe Vertex Company is a services solutions provider that operates as a federal government prime contractor. With over 7,000 employees in 200 locations worldwide, the Mississippi-based compa...
- 22 Days Ago
Pneumatic Aircraft Bench Mechanic
- QUALITY AIRCRAFT PARTS
-
Miami, FL
FULL_TIME
- Quality Aircraft Parts has an immediate opening for an aircraft bench mechanic. This is a full-time position, responsible for repairing pneumatic aircraft components.We are conveniently located near t...
- 15 Days Ago
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0 Quality Manager jobs found in Hialeah, FL area
Quality Manager
- Kantar
-
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- HEICO Corp.
-
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Quality Manager
- Allegheny Technologies Incorporated
-
Pompano Beach, FL
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- 4/19/2024 12:00:00 AM
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- Peak Performance Recruitment
-
Miami, FL
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- 4/18/2024 12:00:00 AM
Quality Manager
- Trinity Search Group
-
Fort Lauderdale, FL
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- 4/18/2024 12:00:00 AM
Quality Manager
- The Walsh Group
-
Miami, FL
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- 4/17/2024 12:00:00 AM
Quality Manager
- Trinity Search Group
-
Fort Lauderdale, FL
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- 4/16/2024 12:00:00 AM
Quality Manager
- Crossley Scott
-
Fort Lauderdale, FL
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- 4/15/2024 12:00:00 AM
About Hialeah, Florida
Hialeah ( /ˌhaɪəˈliːə/) is a city in Miami-Dade County, Florida, United States. With the population of 239,673 at the 2018 United States Census, Hialeah is the sixth-largest city in Florida. It is a principal city of the Miami metropolitan area, which was home to an estimated 6,012,331 people at the 2015 census. It is located west-northwest of Miami, and is the only place in the county, other than Homestead, Florida, to have its own street grid numbered separately from the rest of the county (which is otherwise based on Miami Avenue at Flagler Street in downtown Miami, the county seat).
Hialea...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Manager jobs
$90,635 to $117,826
Hialeah, Florida area prices
were up 2.9% from a year ago
were up 2.9% from a year ago
What does a Quality Manager do?
Quality Manager
Assists Sales with all aspects of customer technical service, including product development (R&D), product specification issues and development of new customers/opportunities.
January 18, 2022
Monitors technical, product and process developments and serves as a company technical representative to relevant trade association committees.
February 12, 2022
Required to adhere to the company Quality Policy, and to understand and follow all applicable Quality Work Instructions and Procedures.
March 01, 2022
Communicate with customers to obtain customer scorecards which may entail logon to customer portals to obtain this information.
March 17, 2022
Supports in evaluating and monitoring supplier performance, identifying areas needing improvement and overseeing corrective and preventive actions implemented.
May 30, 2022
Review the customers needs for Quality reporting and insures that all personnel within our organization clearly understands the customer requirements and reporting functions.
June 05, 2022
Implementation of quality objectives and plans to ensure that all employees are involved in integrating quality into their processes to meet quality objectives.
July 15, 2022