Job Summary

The Sr. Quality Specialist II, GXP Training at the Wilson site is responsible for supporting the implementation and maintenance (business administration) of the Learning Management System, implementing processes to quickly identify training gaps, and ensuring timely revisions to existing training when needed, with a focus on the Wilson and RTP sites. Primary duties include the administration of the Learning Management System, and evaluation of existing training programs and data trends to identify training needs and develop new training, including the automation of OJT. This evaluation assesses the adequacy of training materials and programs in a GxP environment. Position will work closely with business units and site management to streamline/progress training needs.

Principle Responsibilities

• Support the identification and implementation of improvements to the training function to make it more effective and efficient in supporting business objectives and compliance requirements.
• Work with site personnel to develop training curricula and materials that meet business needs.
• Support training needs analysis and effectiveness assessments and deliver program changes as deemed appropriate.
• Coordination with departmental training SMEs (train the trainer) to ensure effective delivery of all regulated training.
• Ensure training documentation is accurate and compliant with Good Documentation Practices.
• Develop and implement training programs to improve training effectiveness, current practices and optimize operations.
• Establish and maintain industry contacts on current compliance and training issues by participating in external Training industry groups.
• Proactively support company priority initiatives.
• Ensure timely maintenance of GXP training files, ensure GXP files are current and in compliance with regulations and internal procedures.
• Coordinate with Quality Management to provide training records as requested in support of external and internal audits.
• Provide Quality GxP Training SME input on deviations, Laboratory Investigations, Planned Deviations, Change Controls and CAPAs.
• Other assigned responsibilities as required.

Education and Experience Requirements

Sr Quality Specialist II must have:

BS required and 8 years minimum experience, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS preferred) with 6-10 plus years’ experience or PhD with 3-6 plus years’ experience.

Necessary Knowledge, Skills, and Abilities

The Sr. Quality Specialist II (Knowledge):

• Proficient in understanding GxP training requirements and the impact on products in development and commercialized. Understand the organization’s business agenda.
• Proficient in assessing data to ensure compliance with applicable GxP regulations, guidance, and internal SOPs.
• Maintain current knowledge base within relevant technical discipline of FDA regulations and awareness of the necessity and impact of compliance on the business.
• Possess effective interpersonal, verbal, and listening skills. Knowledge of and adherence to appropriate laws and regulations are critical. Proficient in MS Office software and applications

Physical and Environmental

• Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching.
• While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting.
• Ability to work a 10 hour per day/4-day work week, Monday - Friday; 40 hours per week with overtime as required.

Additional Information

The Sr. Quality Specialist II (Communication)

• Must maintain open communication across the organization with all levels of management in order to assess the compliance status of training.
• Timely resolve training record requests and decisions thereby minimizing impact on project timelines and ensuring uninterrupted business flow.
• Open communication must be maintained with client departments in order to schedule assessments and follow up on issues to be resolved.
• Anticipate challenges and drives full understanding of problems faced within the team.
• Drive the analysis and change management process for how we solve problems and reach goals.
• Think broadly about the causes of problems, their impact, and their solutions.
• Build in controls to prevent future problems, using experience and awareness to identify problems early.

The Sr. Quality Specialist II (Leadership/Data Review):

• Drive initiatives to energize and challenge colleagues and teams to think in new and novel ways.
• Identify and focus on those ideas and actions with the highest probability of advancing the organization’s business agenda.
• Anticipate and adapt internal and external trends to shape and influence innovative practices across the department / function.
• Openly acknowledge errors as part of the process of innovation, creating an environment where people are not afraid to make mistakes.
• Champion efforts across the department to leverage and adapt innovative ideas and approaches to maximize achievements.
• Train Quality colleagues in processes and procedures, as needed.

The Sr. Quality Specialist II (Degree of Independence):

• Work with multiple functions/sites to ensure the desired outcome is timely.
• Make routine day-to-day decisions within the defined job function.
• Ability to independently prioritize team workload.
• Conduct routine and non-routine activities in primary discipline.
• Plan, perform, and report to management regarding GxP training team or compliance activities.
• Interact with other departments/teams within the Company, with external regulatory agencies and business partners.

Supervisor Responsibilities (if applicable) The Sr. Quality Specialist II reports to the Director, Corporate Quality, and has no direct reports. The direct job responsibilities are described in the “Principal Responsibilities” section of this Job Description.

Relocation is not offered for this position.

Purdue Pharma does not sponsor or facilitate any U.S. work or training authorization for this position. All applicants must have unrestricted and independent authorization to work or participate in an internship or training program at Purdue Pharma.

Minimum required education, experience, knowledge, skills, and abilities for Senior Manager Operations are included in the posting. The position will be filled at the level commensurate with the successful candidate's education, experience, knowledge, skills, and abilities.

The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company may revise the job description at any time.