QA Head

Sun Pharmaceutical Industries Limited; Billerica (MA); On-site; USD 70,000 - 110,000; Full time

Job summary

Join a forward-thinking company that is dedicated to improving global health through high-quality pharmaceuticals. In this key role, you will manage and maintain Quality Systems, ensuring compliance with regulatory standards and delivering exceptional quality in drug products. You will lead initiatives that foster a culture of quality, oversee training programs, and provide expert guidance during audits. This dynamic position offers the chance to make a significant impact in a fast-paced environment, where your expertise will be valued and your contributions will help shape the future of healthcare. If you are passionate about quality assurance and thrive in a collaborative setting, this opportunity is perfect for you.

Benefits

Medical Benefits

Dental Benefits

Vision Benefits

Health Savings Account

Flexible Spending Account

Prescription Drug Coverage

Telehealth Services

Short and Long Term Disability Benefits

401k Company Match

Wellness Programs

Qualifications

• 5+ years of experience in Quality Assurance in a regulated environment.
• Strong knowledge of Quality Management Systems and FDA regulations.

Responsibilities

• Manage development and maintenance of Quality Systems and documentation.
• Ensure compliance with regulatory standards and lead QA initiatives.

Skills

Quality Assurance

Customer Service

Project Management

Communication Skills

Training Development

Aseptic Drug Manufacturing

Continuous Improvement

Presentation Skills

Education

B.A. / B.S. in a related discipline

Tools

eQMS

EDMS

LMS

TrackWise

Job description

COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!

• Medical, Dental, Vision Benefits
• Health Savings Account (HSA), Flexible Spending Account (FSA)
• Prescription Drug Coverage
• Telehealth and Behavior Health Services
• Income Protection – Short Term and Long Term Disability Benefits
• Retirement Benefits - 401k Company Match on Day One (100% vesting immediately)
• Group Life Insurance
• Wellness Programs
• Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods!

Sun Pharma Vision: Reaching People And Touching Lives Globally As A Leading Provider Of Valued Medicines

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $4.5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility. Integrity. Passion. Innovation. It represents our promise to all stakeholders including patients, physicians, and employees.

Our Code of Conduct

Our Global Code of Conduct governs every aspect of our operations. Sun Pharma is a family of thousands of people, working across many countries, speaking multiple languages, and all united, with one common purpose: to make good health accessible and affordable to local communities and society at large. Through active fieldwork, dedicated research teams, and in recognition of the efforts who work behind the scenes to combat illness and disease, the Sun Pharmaceutical Group helps as many people as possible, to secure their right to good health. The way we work every day is important to us.

Manage the development, establishment, and maintenance of Quality Systems

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. Holds overall QA Responsibility at Billerica, MA site. Provide strong leadership and oversight to ensure responsibilities in regards to QA and other QMS activities. The candidate is accountable for assuring the supply of high quality, GMP compliant drug products to Sun Pharma customers and markets. Responsible for leading, directing, identifying and setting quality goals, objectives, and perfect execution in alignment with Global Quality Goals. Candidate will maintain substantial compliance at site, including harmonization and implementation of Quality Systems & procedures in alignment with Global Policies & Standards. Acts as a champion for building a “Culture of Quality” across the site. Accountable to assure the site is ready for all Regulatory and Customer inspections.

• 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)
• Manage electronic learning management system (LMS)
• Manage electronic Quality Management System (TrackWise)
• Administer document and system access rights and revision control to ensure security of system and integrity of master documents
• Analyze, interpret, or disseminate system performance data
• Assist in the development of document or content classification taxonomies to facilitate information, capture search and retrieval
• 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
• 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 deviations
• 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
• Other duties as assigned

Qualifications

• Experience in Quality Assurance, working in a regulated environment in a related field or equivalent required; pharmaceutical/biotech industry preferred
• B.A. / B.S. required, preferably in a related discipline
• 5+ years of related experience in a Pharmaceutical/drug (FDA Regulated) industry required
• 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

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