50 Northern Avenue, Boston, MA 02210 Boston, MA 02210 US
Pay Rate Range: $45-$70/hr depending on experience
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
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