Site Head of Compliance in SUN PHARMA
Date: Oct 28, 2023
Location: Billerica – Sun
Company: Sun Pharmaceutical Industries, Inc (USA)
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
- B.S. 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
The presently-anticipated base compensation pay range for this position is $105,000 to $129,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
The preceding job description has been designed to indicate the general nature and level of work performed by employees 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 the incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives:
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
