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