Sr Compliance Manager

Company: ProStaff Solutions Inc
Location: Billerica
Posted on: June 13, 2022

Job Description:

ProStaff Solutions is looking for Sr Compliance Manager to work with a pharmaceutical company in Billerica, MA. Direct Hire Responsibilities --- 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 --- 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 --- 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 --- Manufacturing / Production Environment --- Operate computer/office machines Qualifications --- 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 --- Must have experience in handling of APQR, Complaints, FAR, Recall, Handling of Critical Quality Investigations and Vendor management and risk assessment --- Knowledge on Quality Review Board (QRB) meetings, Quality Investigation Board (QIB). --- 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 --- 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 --- Close, distance, color and peripheral vision; depth perception, ability to adjust focus --- Lift up to 10 lbs

Keywords: ProStaff Solutions Inc, Billerica , Sr Compliance Manager, Executive , Billerica, Massachusetts