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Actalent Quality Assurance Compliance Manager in Andover, Massachusetts

Please reach out to naburns@actalentservices.com if you or someone you know is interested in this role!

Description:

Manager must possess a strong experience in quality assurance requirements for Biotech/Pharmaceutical facility operations and maintenance perspective. This position is responsible for ensuring that the work conducted by the Facilities Operations and Maintenance teams, and its subcontractors perform the work in full accordance and compliance, client policies and procedures, and FDA cGMP regulations. The Manager role must have a solid understanding of cGMP’s as they relate to the performance of maintenance and repairs to equipment utilized for the manufacturing of drug products and control of workplace environment. Ensure staff and subcontractors are compliant with all client and regulatory training.

QC Manager must have a strong commitment to quality assurance, and a willingness to support the quality first culture for Life Sciences accounts. Must be self-motivated, detail oriented and comfortable working in a dynamic team environment with minimal supervision.

Essential Duties:

 Ensure client satisfaction with delivery of facility management services and provide a lead role in monitoring and increasing regulatory and statutory compliance.

 Develop excellent partnership with clients through trust, actions and results

 Comply with all GMP and Non-GMP requirements of the Client contracts and meet or exceed key performance indicators.

 Deliver an exceptional quality of service to the clients, as reflected by client feedback.

 Ensure training compliance within scope of work.

 Be an active member of the Life Sciences Quality Council, participate in and lead initiatives, share learnings with the council and share best practices and improvement to the accounts Leadership Management (People)

 Foster a proactive environment of teamwork, cooperation, excellence of performance and personal success.

 Act as role model by behaving consistently with cultural, ethical requirements and participating in company activities.

 Support individual performance management program, and responsible for personal development planning process.

 Promote safety culture within portfolio including clients, subcontractors, suppliers and visitors.

 In collaboration with managers, develop training curriculum for all staff and subcontractor roles within scope of work.

Skills:

Quality assurance, Audit, KPI, Deviation, ASQ, ASQ certified, GXP vendor, QMS

Additional Skills & Qualifications:

Account Specific Responsibilities:

 Audit GxP Work Orders sample sets and GxP documentation for completeness and accuracy

 KPI Scorecard review and governance

 Participate, prepare, and lead, if applicable, internal and external audits

 Provide Quality training as needed

 Coordinate and manage GxP vendors, including vendor qualification packages, audits, and monitoring service performance

 CAPAs creation, review, closeout and lessons learned

 Assure ongoing compliance with Quality, Client Quality, and Regulatory requirements

 Prepare reports to communicate outcomes of quality activities

 Interpret and implement quality assurance standards

 Draft and execute client quality agreements

 Lead Significant Events/Deviations investigations

 Review GxP Change Management

Qualifications:

 BA/BS in engineering is preferred, or equivalent quality engineering and production/facility operations experience.

 Have a minimum of four to seven (4+) years of regulatory quality and statutory compliance experience

 Have a minimum of five (5+) years of experience in Pharma, Biotech or similar life science sector that are governed in GMP regulations, systems and processes working in a Quality Assurance role.

 Knowledge of Quality Engineering techniques, CMMS systems, and Quality Management Systems

 Proven record of excellent internal and external customer service

 Excellent verbal and written communication skills

 Advanced computer and office software skills is require

Experience Level:

Expert Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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