SUN PHARMA
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Senior Manager, Site Compliance Head
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Senior Manager, Site Compliance Head
role at
SUN PHARMA Job Summary
Manage the cGMP compliance at site focusing on Quality Systems, processes, procedures and controls ensuring that the cGMP documentation and records conforms to established standards and in compliance to regulatory requirements. Job Summary
Manage the cGMP compliance at site focusing on Quality Systems, processes, procedures and controls ensuring that the cGMP documentation and records conforms to established standards and in compliance to regulatory requirements.
Area Of Responsibility
Implement and manage the records in electronic Quality Systems, such as QMS, EDMS, and LMS, etc. providing procedures and training for employees to effectively use the electronic Quality Systems 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 and vendor audits. Facilitate and follow up with stakeholders with regard to responses to audit observations Prepare annual internal audit schedule and perform execution of the 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 point of contact with corporate activities and projects. Issuance of Quality Alerts, coordinate with Corporate Quality team for FAR/Recall as per 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.
Experience
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
Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at SUN PHARMA by 2x Sign in to set job alerts for “Senior Compliance Manager” roles.
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Senior Manager, Site Compliance Head
role at
SUN PHARMA 1 day ago Be among the first 25 applicants Join to apply for the
Senior Manager, Site Compliance Head
role at
SUN PHARMA Job Summary
Manage the cGMP compliance at site focusing on Quality Systems, processes, procedures and controls ensuring that the cGMP documentation and records conforms to established standards and in compliance to regulatory requirements. Job Summary
Manage the cGMP compliance at site focusing on Quality Systems, processes, procedures and controls ensuring that the cGMP documentation and records conforms to established standards and in compliance to regulatory requirements.
Area Of Responsibility
Implement and manage the records in electronic Quality Systems, such as QMS, EDMS, and LMS, etc. providing procedures and training for employees to effectively use the electronic Quality Systems 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 and vendor audits. Facilitate and follow up with stakeholders with regard to responses to audit observations Prepare annual internal audit schedule and perform execution of the 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 point of contact with corporate activities and projects. Issuance of Quality Alerts, coordinate with Corporate Quality team for FAR/Recall as per 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.
Experience
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
Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at SUN PHARMA by 2x Sign in to set job alerts for “Senior Compliance Manager” roles.
Senior Manager, Compliance Business Partner
Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (Senior Director)
Boston, MA $208,200.00-$327,140.00 1 day ago Boston, MA $171,000.00-$274,000.00 3 days ago Compliance Operations Lead, Associate Director (Hybrid)
Boston, MA $153,600.00-$241,340.00 1 day ago Compliance, Audit & Investigations Senior Manager
Sr. Manager, R&D Quality Operations & Compliance
Regulatory Compliance – Associate Director, Marketing
Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (Senior Director)
Boston, MA $208,200.00-$327,140.00 2 weeks ago Merrimack, NH $103,000.00-$174,000.00 1 week ago Merrimack, NH $103,000.00-$174,000.00 6 days ago Director, Advertising and Promotional Compliance, US
Andover, MA $138,500.00-$335,500.00 1 week ago Associate Director, Clinical Research, Value & Evidence Generation, US Medical
Lexington, MA $153,600.00-$241,340.00 1 week ago Senior Director/Director of Tax Operations and Compliance
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Lexington, MA $153,600.00-$241,340.00 3 weeks ago Boston, MA $104,383.00-$117,431.00 3 months ago Experienced F&I Director for High Volume Honda Store
Reading, MA $180,000.00-$350,000.00 1 week ago Boston, MA $75,000.00-$85,000.00 2 weeks ago Director, Corporate Compliance, North America
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Cambridge, MA $148,125.00-$213,958.33 6 days ago Waltham, MA $215,000.00-$245,000.00 1 month ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr