Sr. Compliance Manager

Billerica, MA

Posted: 12/28/2022 Industry: Scientific Job Number: 22-01393

Job Description

Job Summary

Manage the development, establishment, and maintenance of Quality Systems, policies, processes, procedures and controls ensuring that performance and quality of cGMP documentation and records conforms to established standards.

Area Of Responsibility

Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems

Design, plan, implement, and manage documentation programs, policies, and procedures that support company objectives and regulatory requirements

Supervise the QA Documentation department in the creation, issuance, maintenance, archiving, and storage of cGMP and cGXP controlled documentation and records

Manage electronic document processing, retrieval, and distribution systems (EDMS), electronic learning

management system (LMS), electronic Quality Management System (TrackWise), etc.

Administer document and system access rights and revision control to ensure security of system and integrity of master documents

Lead Monthly Quality Review Board (QRB) meetings, Quality Investigation Board (QIB)

Supervise the creation of an annual training calendar and other training initiatives at the site

Provide expertise and input to other functional areas affecting controlled documents and records

Assist with FDA and other compliance audits including corporate audits.

Facilitate and follow up with stakeholders with regard to responses to audit observations

Prepare annual internal audit schedule and perform execution of same

Oversee site vendor management program including performing annual vendor risk assessment

Oversee harmonization efforts between corporate and plant Quality procedures and policies

Provide QA review of Annual Product Reviews (APRs) to identify trends and recommend CAPA as needed

Provide QA review of quality events such as unplanned/planned deviations and change controls

Participate in investigation team efforts to determine root cause for critical quality events and recommend appropriate CAPA

Develop presentation materials for upper management to disseminate on the topics of quality issues, QMS initiatives, and related projects

Participate in Regional Quality related projects and initiatives, acting as an ambassador between corporate and plant

Issuance of Quality Alerts, FAR/Recall as per internal procedures

Other duties as assigned

Work Conditions: Office Environment Manufacturing / Production Environment Warehouse Environment Field Familiarity Environment

Physical Requirements: Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, hear or talk, taste or smell Operate computer/office machines Gowning, safety glasses, gloves, booties Close, distance, color and peripheral vision; depth perception, ability to adjust focus Lift up to 10 lbs.

Travel Estimate Up to 10%

Education and Job Qualification

BS in chemistry or related scientific field

Minimum ten (10) years of related experience in pharmaceutical (manufacturing) environment, biotech industry, Quality Assurance, Quality Control and/or production, or FDA regulated industry.


Strong working knowledge of a Quality Management System (QMS) and adherence to 21 CFR Parts 210, 211; aseptic drug manufacturing experience a plus

Superior internal and external customer service/people skills

Ability to manage multiple responsibilities and training projects in a fast paced environment, in an efficient manner

Ability to present self in a professional, credible manner and communicate effectively at all levels of the organization

Ability to prioritize and organize own work, multi-task, meet deadlines and keep commitments

Experience in developing and managing various types of training initiatives expected

Excellent administrative & organization skills

Strong presentation and MS Power Point Skills

Positive attitude; values others and works well independently and in a team environment

Excellent verbal, written and interpersonal communication skills

Works under minimal supervision following established procedures along with own judgment.

Expert knowledge of electronically based Quality Systems

Working knowledge of pharmaceutical and medical device documentation and change controls

Experience with continuous improvement programs and project management skills

Working knowledge of applicable domestic and international standards and regulations

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.

Meet Your Recruiter

Alyssa Darden

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