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Site Compliance Head

Billerica, Massachusetts

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  • Full Time
  • Level: Entry
  • Glassdoor Reviews and Company Rating

Overview

You’re the one who will help us meet and exceed the quality standards that medical professionals and patients expect from us. Collaborating with like-minded, inventive colleagues, you’ll take a balanced approach, tackling challenges, learning from mistakes, and creating solutions that empower our fast-growing company. Join a workplace that’s big on open communication and fueling your career growth. When can you start?

Success Profile

What makes a great Site Compliance Head at Sun Pharma? Take a look and see how you match up.

  • Collaborative
  • Communicator
  • Detail-oriented
  • Independent
  • Problem-solver
  • Team player

Our Culture

Discover an environment that’s open and transparent. Every day is a new opportunity to learn and grow, surrounded by powerful reminders of the impact your role has on patients’ lives. This is the Sun Pharma way of life. And we can’t wait for you to be a part of it.

Benefits

We’re in your corner – in so many different ways. Sun Pharma wants you to have the benefits, support, and rewards of a job well done.

  • Career Growth

    Get support for your career growth and development.

  • Benefits Programs

    Discover comprehensive benefits to support the health and wellness of you and your family.

  • Time Off

    Enjoy paid time off and leave-of-absence options.

  • Compensation

    Earn competitive compensation with incentive programs that reward our shared success.

  • Working Conditions

    Work confidently in the safe, clean, and regulated work environment that we foster.

  • Team Environment

    Collaborate in a workplace that’s rooted in our values and encourages cross-team engagement.

Site Compliance Head

Billerica, Massachusetts
Category Quality Job ID R-44491
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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

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

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