Senior Manager Corporate Quality Training | Sun Pharma | Baroda

Job Description

Position Overview:

The Senior Manager of Corporate Quality Training Programs will partner with Corporate leadership to ensure for managing the development, implementation, and execution of corporate Quality Training Programs related to key compliance initiatives, applicable regulatory requirements, and local and global processes, and for the continuous improvement of compliance across Sun Pharma.

The Senior Manager of Corporate Quality Training Programs will lead the design and development of Certification programs focused on improving cGMP compliance and is expected to partner with key stakeholders to ensure Certification programs are properly maintained, implemented, and communicated across sites.

Responsibilities:

• Responsible for the development, implementation, and management of Corporate Quality Training Programs that support compliance objectives, applicable to regulatory requirements, and local and global processes.
• Manage the in-house or outsourced, global certification programs based on the company’s demand.
• Accountable for the creation and management of course curricula and evaluation tools with the objective of maintaining a state of audit readiness and aligning training requirements with business and employee needs.
• In partnership with relevant parties, establish role competencies, expectations towards certification, and customization of the training material if needed. Ensure that course materials are customized and continually revised to accurately reflect organization, regulatory, or business process changes.
• Work in partnership with a team of trainers and Subject Matter Experts (SMEs) and ensure that training and certification programs are developed utilizing the most effective methodologies (e.g. Classroom, e-Learning, pre-assessments, and assignments).
• Ensure that all certification training documentation is consistently and systematically maintained in a timely and effective manner, in compliance with relevant regulations. This includes course materials and training records.
• In partnership with site training personnel ensure traceability of training completion and develop and maintain training metrics towards measurement of success and effectiveness.
• Assess training program and qualification strategy effectiveness at the site level and provide local support as necessary.
• Ensure timely relevant solutions and training programs are in place to address strategic learning requirements, customer needs and compliance commitments.
• Internal, external, regulatory, and customer audits when required.
• Interact with other Corporate Quality individuals to assure quality systems and procedures for use in reporting monthly metrics (KPIs).
• Maintain systems to track and trend key quality system indicators and ensure monthly KPIs are issued on time and any deficiencies noted are promptly addressed.
• Ensure consistent and flexible approach towards global region’s time zones and travel if required to deliver training.
• Work as a member of a team to achieve all outcomes.
• When necessary, maintains short-term performance goals, and training plans, and monitors results to reflect a changing environment.
• Maintain a working knowledge of EDMS, LMS, and other software relevant to the training program to allow proper communication with stakeholders
• Develop and maintain the curriculum for the training programs in LMS
• Identify global learning tools and solutions that enable access to critical learning content “on demand” to support real-time training (websites, shared drives, video tools, etc.)
• Participate and/or conduct regular Corporate Training update meetings with site training coordinators (forum) as required
• All other duties as assigned

Desired Candidate Profile:

Education Requirement:

Bachelor’s degree (BA/BS) in Life Sciences, Pharmacy, or equivalent required, with an MA preferred

Experience Requirement:

• +10 years working in a pharmaceutical environment
• Strong understanding of GMP requirements and their application in a manufacturing environment, knowledge of international GMP requirements
• Working experience in the design and implementation of training programs, LMS, Trackwise, and LIMS is preferred

Additional Skills:

• Ability to function as a project manager with a multicultural team in a global environment
• Excellent communication, presentation, technical writing, and interpersonal skills
• Ability to work independently, take initiative, and lead, inspire, and motivate a team
• Ability to remain focused and effective in high-stress situations
• Computer Literate (MS Office, MS Project or equivalent)
• Must have English language fluency; both Written and Verbal, with the ability to communicate at all levels within the organization