Job Description

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates.

Job Title: Quality Assurance Associate - Training & Compliance

Work Location: Fall River, MA

Work Hours: General: 8:30AM – 5:00PM (may vary based on business needs)

Reports To: QA QMS Lead

Salary Range: $66,300 - $86,000

Purpose

The QA Associate is responsible for the quality systems processes, continuous improvement of the site's training, strategic administration and document management. The role independently manages quality system initiatives, evaluates training effectiveness and compliance risks, leads process improvement activities, provides recommendations to management, and serves as a key quality systems resource to support regulatory compliance and operational excellence.

Job Responsibilities

Quality Systems & Change Management

1. Independently initiate, own, and manage change controls related to training systems, document management processes, and Quality Systems improvements.
2. Perform impact assessments and risk evaluations for quality system changes and recommend implementation approaches.
3. Lead cross-functional change control activities to ensure effective execution, compliance, and timely closure.
4. Identify process gaps through audits, trend analysis, investigations, inspection observations, and management review activities.
5. Recommend and implement continuous improvement initiatives that reduce compliance risks and improve quality system effectiveness.
6. Analyze quality metrics and compliance data to identify emerging trends and provide recommendations to site leadership.
7. Support management in establishing quality system objectives, compliance strategies, and training governance initiatives.
8. Lead or independently manage projects related to training systems, document management, digital transformation, and quality process improvements.
9. Participate in investigations involving training effectiveness, procedural compliance, or document management issues and provide impact assessments and recommendations.
10. Provide consultation and guidance to management regarding regulatory expectations, training compliance strategies, and quality system best practices.
11. Perform additional quality systems leadership responsibilities as assigned by Head Unit QA and Head Site Quality.

Master Control & Document Management Leadership

1. Serve as site SME for Master Control document and training management systems.
2. Independently evaluate system issues, user concerns, and process inefficiencies and recommend corrective or preventive actions.
3. Assess quality system impacts of document revisions and determine appropriate implementation and training strategies.
4. Lead document control process improvement initiatives to enhance compliance, efficiency, and user experience.
5. Review audit trail trends, identify potential compliance concerns, perform impact assessments, and recommend remediation plans.
6. Provide guidance to departments regarding document management practices, change implementation strategies, and compliance requirements.
7. Partner with global/site stakeholders to support MasterControl enhancements, upgrades, and system optimization initiatives.

New Hire & Training Program Management

1. Develop, maintain, and continuously improve the site's new hire qualification and onboarding program to ensure compliance with cGMP, regulatory, and business requirements.
2. Evaluate training effectiveness through periodic review of training data, competency assessments, deviations, audit observations, and performance trends, and recommend improvements to management.
3. Independently assess training requirements for new roles, functions, and organizational changes and recommend qualification pathways.
4. Lead training curriculum reviews and recommend modifications to ensure compliance with changing regulatory and operational requirements.
5. Analyze sitewide training metrics and provide recommendations to department leadership regarding compliance trends, overdue training risks, and resource needs.
6. Serve as the site subject matter expert (SME) for training systems and qualification requirements.
7. Advise the management regarding employee qualification status and readiness for critical operations.

Site Training Governance

1. Manage and oversee the training matrix structure in MasterControl to ensure alignment with organizational and regulatory requirements.
2. Evaluate departmental requests for job code creation, modification, and training assignment changes, and determine appropriate implementation strategies.
3. Assess training impact associated with new procedures, process changes, organizational changes, and quality system events.
4. Lead periodic reviews of training programs to identify process gaps, compliance vulnerabilities, and opportunities for continuous improvement.
5. Recommend actions to management when training deficiencies, recurring failures, or systemic compliance risks are identified.
6. Lead projects to improve training system effectiveness, compliance performance, efficiency, and inspection readiness.
7. Participate in regulatory inspections and independently address training system-related inquiries from auditors and inspectors.
8. Detect any deviation related to training related discrepancies across all the department.

Educational & Experience:

• Minimum of a bachelor’s degree in chemistry, Pharmaceutical Sciences, Quality Management or related field of study from an accredited institution.
• Minimum of two (2) years of experience with New Hire & training Program Management, Site Training Governance, MasterControl & Document Management Leadership and Quality Systems & Change Management
• Working knowledge and direct application of cGMP and regulatory guidelines related to QA, pharmaceutical manufacturing.
• Relevant understanding and knowledge about CFR part 11 regulations, CFR part 820 regulations.
• Preferably have prior MDI experience or in Drug Device combination products.

About CiplaCipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India’s pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Driven by the purpose ‘Caring for Life’, Cipla’s focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.InvaGen Pharmaceuticals, Inc.InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla’s respiratory business in the United States.Equal Opportunity EmployerCipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.

About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.