Senior Manager - Quality Systems Contractor
Senior Manager - Quality Systems Contractor
Posted on :
22-04-2025
Employer Active
1 Vacancy
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Hourly Salary
USD 70 - 75
Vacancy
1 Vacancy
Posted on :
22-04-2025
Job Description
Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams. All communication will come from an email address ending If you receive a message that seems suspicious or is not from our official domain please report it immediately toemailprotected.
This is a temporary 6month contracted 1099 position withno benefits.
This is a hybrid role (TuWTh) MF as needed.
POSITION SUMMARY:
We are seeking an experienced QMS Senior Manager to lead our quality management system initiatives and ensure the highest standards of product quality and regulatory compliance. The successful candidate will be responsible for overseeing and managing a wide range of quality processes related to quality systems audits harmonization of quality system processes finished product release and equipment administration in accordance with regulatory standards such as 21 CFR Partsand 11 ISO 13485 and ICH Guidelines. Additionally the individual shall employ independently selected methods / techniques and execute indepth evaluations to address and resolve complex objectives and problems including interface with internal and external resources when judged to be necessary.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
EDUCATION EXPERIENCE KNOWLEDGE SKILLS AND ABILITIES:
ENVIRONMENTAL CONDITIONS:
Physical Activities: On a continuous basis be at a desk for a long period of time; intermittently answer the telephone and type on a computer. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate.
The physical requirements described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities of this job.
#LIRS1
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams. All communication will come from an email address ending If you receive a message that seems suspicious or is not from our official domain please report it immediately toemailprotected.
This is a temporary 6month contracted 1099 position withno benefits.
This is a hybrid role (TuWTh) MF as needed.
POSITION SUMMARY:
We are seeking an experienced QMS Senior Manager to lead our quality management system initiatives and ensure the highest standards of product quality and regulatory compliance. The successful candidate will be responsible for overseeing and managing a wide range of quality processes related to quality systems audits harmonization of quality system processes finished product release and equipment administration in accordance with regulatory standards such as 21 CFR Partsand 11 ISO 13485 and ICH Guidelines. Additionally the individual shall employ independently selected methods / techniques and execute indepth evaluations to address and resolve complex objectives and problems including interface with internal and external resources when judged to be necessary.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
- Administer and monitor quality processes ensuring conformance to regulatory standards and track operational performance to identify improvement opportunities.
- Conduct data collection and analysis to support investigations and corrective actions
- Manage the issuance of batch records for GMP production. Prepare and review lot number and expiration date calculations and ensure compliance of batch records with GXP requirements.
- Compile product release records into the eQMS system issue product shipment authorizations.
- Assist in the maintenance and issuance of logbooks.
- Schedule calibration activities support equipment qualification processes and interface with crossfunctional teams to ensure compliance to equipment administration program.
- Collaborate with other departments to maintain compliance and ensure product quality and patient safety.
- Facilitate the gathering of data for performance metrics conduct training and support audits and inspections by health authorities and third parties.
- Lead and manage aspects of quality systems including CAPA Management Review Deviation Management and Supplier Quality while evaluating performance and compliance of quality system documentation.
- Drive continuous improvement efforts through the development and implementation of systems and resources and lead the effort in screening document changes.
- Lead preventative action activities to support implementation of changes to 21 CFR Part 820 utilizing ISO13485 as its foundation.
- Lead and support internal and external audits participate in supplier audits and manage the field action process to ensure timely compliance.
- Support the complaint team in the review and investigation of customer complaints including assessment of complaint outcomes for Medical Device Reports (MDR).
- Participate in Quality System harmonization activities across allsites.
- Support Software Quality Assurance team in the utilization of eQMS software for manufacturing and quality event activities.
- Communicate effectively with all groups and lead/manage the quality system team providing mentorship to team members
- Other duties as assigned
EDUCATION EXPERIENCE KNOWLEDGE SKILLS AND ABILITIES:
- Minimum BS/BA degree in a scientific or technology field such as Engineering.
- Minimum 8 years of experience the life science industry.
- Minimum 5 years of experience in supervising a diverse group of employees.
- An equivalent combination of experience and education may be considered
- The candidate will possess broad experience within the Quality function combining excellent technical expertise and strong crossfunctional communications skills.
- The candidate will be a problemsolver with the ability to exercise sound judgment under challenging circumstances.
- Excellent communication skills with the ability to effectively promote intraand interorganizational cooperation.
- Indepth knowledge of GXP 21CFR EU GMP ICH ISO QSR and other applicable Regulations Standards Directives and Guidance with handson experience in their interpretation and application to ensure compliance through practical and progressive approaches is achieved and maintained.
- Possessing strong character with selfconfidence and integrity necessary to ensure that the bestinterests of product recipients and customers are always of first and foremost importance.
- Strong background in a manufacturing and operations environment preferably supporting drugdevice combination products medical devices and/or asepticallyproduced pharmaceutical products.
- Experience working within vertically integrated and virtuallystructured settings for small to midsized organizations is preferred.
- Strong background in administering and optimizing quality systems.
- Sound technical background and the ability to educate stakeholders management and customers pertaining to quality assurance/control principles and techniques.
- Ability to interface with internal customers at all levels and 3rdparty partners.
- Technical equipment software knowledge necessary
ENVIRONMENTAL CONDITIONS:
Physical Activities: On a continuous basis be at a desk for a long period of time; intermittently answer the telephone and type on a computer. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate.
The physical requirements described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities of this job.
#LIRS1
Required Experience:
Manager
Employment Type
Full-Time
Key Skills
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