Connexion Systems + Engineering
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Quality Manager, Continuous Improvement - Boston MA - 17495
Boston, MA 02210 US
Posted: 02/02/2023
2023-02-02
2023-04-27
Industry: Scientific and Life Sciences
Job Number: 15284
Job Description
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: Quality Manager – Continuous Improvement
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
GENERAL POSITION SUMMARY: The Quality Manager – Continuous Improvement, is knowledgeable in the principles and application of quality assurance and compliance. The Quality Manager is responsible to support continuous improvement within the GMP Operational Quality group at the Manufacturing Center. The role will focus on enhancing compliance and ensuring real time inspection readiness of the site. The Quality Manager supports multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.
This position reports to the Associate Director, GMP Operational Quality – Continuous Improvement
KEY KNOWLEDGE/ SKILLS AND COMPETENCIES:
• Risk Management experience
• Investigation, CAPA, and Change Control experience
• Experience in developing leading quality system metrics
• Lean/Six Sigma certification or understanding of Lean principles
• Excellent technical writing, presentation and communication skills
• Ability to thrive in a high throughput environment
• Project Management experience
• Collaboration / Teamwork / Conflict Management
o Ability to independently support cross-functional teams and represent the Quality unit
• Communication/ Influencing
o Ability to effectively influence others within technical area of expertise
o Ability to communicate effectively across all organizational levels
• Critical Thinking / Problem Solving
o Ability to evaluate quality matters and make decisions utilizing risk based approach
• Flexibility/Adaptability
• Attention to detail
• Knowledge in the following areas:
o Global GMP requirements governing oral drug products and knowledge of oral drug product
manufacturing practices
o Knowledge of ASTM E2500, CSV/GAMP, ICH Q9 and other associated standards
o Demonstrated ability to work independently to provide QA support for large, multifaceted projects
KEY RESPONSIBILITIES:
The position is responsible to ensure the successful execution of, but is not limited to, the following:
• Compliance Initiatives
o Responsible for CAPA management – accountable for on time completion and effective CAPAs at the site
o Responsible for change management – accountable for on time completion and effective changes at the site
o Development of leading metrics and advancement of reporting for operational review
o Buildout process for site risk management – to include gap assessment evaluation from inspections
o Proactively monitor site compliance metrics to ensure meeting/ exceeding expectations
o Participate in continuous improvement initiatives
? Including projects resulting from value stream mapping activities
o Support team projects as needed (e.g: Quality Agreement process improvements, training enhancement (and others as identified)
• Real-time Inspection Readiness
o Provide feedback to site Inspection Readiness Plans associated with regulatory filings
o Participate in and follow up on activities from compliance walkthroughs
• Individual Development and Training
o Responsible for timely completion of trainings, goal development, self-evaluation and IDP
Other Activities
• Represents Quality on cross-functional working teams, applying strong communication and collaboration
skills.
• Identify areas of improvement and participate in process improvement initiatives
• Additional as needed support to processes, systems, procedures to ensure continuous Quality improvement
• Additional activities as needed to support the Manufacturing Center Operational Quality Team.
• Author/Revise Standard Operating Procedures
MINIMUM QUALIFICATIONS:
• Bachelor’s degree in a scientific or allied health field and 8+ years of relevant work experience, or Master’s degree with 5+ years relevant experience, or relevant comparable background
• Candidate must have experience in a Quality Assurance role supporting or relevant experience
• Demonstrated success independently leading cross-functional projects
PREFERRED QUALIFICATIONS:
• Operational QA experience in analytical or manufacturing setting with experience with the following is preferred:
o Inspection support roles
o Quality System background
o Conducting investigations, performing Root Cause Analysis and identifying CAPA
o Drug product (oral solid dosage forms preferred) development and manufacturing
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
When responding to this job posting you MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!
Title: Quality Manager – Continuous Improvement
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: Temp
- Job Location: Boston MA (hybrid)
- Job#: bh15284
GENERAL POSITION SUMMARY: The Quality Manager – Continuous Improvement, is knowledgeable in the principles and application of quality assurance and compliance. The Quality Manager is responsible to support continuous improvement within the GMP Operational Quality group at the Manufacturing Center. The role will focus on enhancing compliance and ensuring real time inspection readiness of the site. The Quality Manager supports multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.
This position reports to the Associate Director, GMP Operational Quality – Continuous Improvement
KEY KNOWLEDGE/ SKILLS AND COMPETENCIES:
• Risk Management experience
• Investigation, CAPA, and Change Control experience
• Experience in developing leading quality system metrics
• Lean/Six Sigma certification or understanding of Lean principles
• Excellent technical writing, presentation and communication skills
• Ability to thrive in a high throughput environment
• Project Management experience
• Collaboration / Teamwork / Conflict Management
o Ability to independently support cross-functional teams and represent the Quality unit
• Communication/ Influencing
o Ability to effectively influence others within technical area of expertise
o Ability to communicate effectively across all organizational levels
• Critical Thinking / Problem Solving
o Ability to evaluate quality matters and make decisions utilizing risk based approach
• Flexibility/Adaptability
• Attention to detail
• Knowledge in the following areas:
o Global GMP requirements governing oral drug products and knowledge of oral drug product
manufacturing practices
o Knowledge of ASTM E2500, CSV/GAMP, ICH Q9 and other associated standards
o Demonstrated ability to work independently to provide QA support for large, multifaceted projects
KEY RESPONSIBILITIES:
The position is responsible to ensure the successful execution of, but is not limited to, the following:
• Compliance Initiatives
o Responsible for CAPA management – accountable for on time completion and effective CAPAs at the site
o Responsible for change management – accountable for on time completion and effective changes at the site
o Development of leading metrics and advancement of reporting for operational review
o Buildout process for site risk management – to include gap assessment evaluation from inspections
o Proactively monitor site compliance metrics to ensure meeting/ exceeding expectations
o Participate in continuous improvement initiatives
? Including projects resulting from value stream mapping activities
o Support team projects as needed (e.g: Quality Agreement process improvements, training enhancement (and others as identified)
• Real-time Inspection Readiness
o Provide feedback to site Inspection Readiness Plans associated with regulatory filings
o Participate in and follow up on activities from compliance walkthroughs
• Individual Development and Training
o Responsible for timely completion of trainings, goal development, self-evaluation and IDP
Other Activities
• Represents Quality on cross-functional working teams, applying strong communication and collaboration
skills.
• Identify areas of improvement and participate in process improvement initiatives
• Additional as needed support to processes, systems, procedures to ensure continuous Quality improvement
• Additional activities as needed to support the Manufacturing Center Operational Quality Team.
• Author/Revise Standard Operating Procedures
MINIMUM QUALIFICATIONS:
• Bachelor’s degree in a scientific or allied health field and 8+ years of relevant work experience, or Master’s degree with 5+ years relevant experience, or relevant comparable background
• Candidate must have experience in a Quality Assurance role supporting or relevant experience
• Demonstrated success independently leading cross-functional projects
PREFERRED QUALIFICATIONS:
• Operational QA experience in analytical or manufacturing setting with experience with the following is preferred:
o Inspection support roles
o Quality System background
o Conducting investigations, performing Root Cause Analysis and identifying CAPA
o Drug product (oral solid dosage forms preferred) development and manufacturing
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
When responding to this job posting you MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!
