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Actalent Quality Assurance Compliance Manager in Boston, Massachusetts

We are looking for a Quality Assurance Compliance Manager to join out team! If you are interested please reach out to Clare Parsells at cparsells@actalentservices.com or (781) 356-6907

Description:

Manager must possess a strong background 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 with 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:

Customer Relationships (Client)

 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 for 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.

Service Delivery (Growth)

 Primary responsibility is to lead regulatory and quality assurance programs and requirements in a GxP

environment by ensuring all facilities services and documentation in full accordance and compliance with

client policies and procedures, and FDA cGMP regulations.

 Accountable to provide specific quality assurance assistance to the facility management teams as needed

or requested.

 Responsible for executing the Quality Compliance program for cGMP manufacturing facilities such as

training verification, facility self-assessment, documentation control, personnel qualification files,

vendor/suppliers audits and site programs relating to regulatory or statutory compliance.

 Reads and understands the applicable Service Level Agreements, helps achieve the Key Performance

Indicators and scores favorably on the client satisfaction surveys.

 Support EHS teams in full compliance with all EHS programs requirements.

 Responsible to prepare and revise SOP’s, change control documentation, investigations, discrepancies,

CAPA’s, GDP’s and training materials used by the facilities maintenance team in the performance of their

work and also is accountable to keep updated applicable quality management system or software (Ex.

TrackWise) in place.

 Interface with the client’s SME’s to ensure that applicable client SOP’s are followed, and that the work

performed by the team is documented and recorded for accuracy and compliance with all applicable

regulations, international standards, and internal procedures.

 Review, consult, and approve (as authorized) risk analysis performed for facilities operation at site level.

 Support new hire induction program and validate sub-contractor’s services against contract/service

labor agreement.

 Comply with all GMP and Non-GMP requirements of the client contract and meet or exceed key

compliance requirements.

 Ensure compliance of all regulatory laws and guidelines are met in accordance to their SOP’s by

maintaining practices across all facilities services to meet client and authority having jurisdiction

(AHJ) compliance requirements.

 Lead in the completion of the facilities operations audits and assessments requirements, and full

responsible of site audit readiness program.

 Support Business Continuity Planning activities, and participate as a key team member in responses to

emergency situations.

 Provides direction/information to vendors, facilities staff and service providers as required to ensure that

quality assurance expectations are communicated and followed.

 Owns program processes and ensures all requirements for facility are met.

 Execute additional job duties as requests, analysis and reporting.

 Seeks to continuously improve quality processes, systems and overall client satisfaction.

Skills:

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

Top Skills Details:

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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