Senior Specialist, Quality Assurance – Documentation and Training Management

Job Description

Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world.

The Compliance and Quality Management Systems (CQMS) organization is part of the larger Global Development Quality (GDQ) organization within our company's Research Laboratory (MRL) Quality Assurance under Global Regulatory Affairs and is accountable for the execution of critical activities in the areas of compliance, quality systems, regulatory intelligence, and the Quality Management System (QMS).

This position reports to the Associate Director, Quality Assurance and plays a key role in the operation, monitoring, and continuous improvement efforts of the standard operating procedures (SOP) and training management quality systems supporting Global Development Quality as well as clinical supply sites performing clinical supply functions within our company's Global network.

Specifically, this role is critical to meet SOP and training system requirements and serve as a document life cycle manager for QMS Quality Standards, Global Procedures and Local Procedures (SOPs). In addition, this role provides oversight of assignments of learning roles, training rosters and other training evidence to update the Learning Management System in a GXP environment. This position will support further responsibilities as outlined below.

Responsibilities include, but are not limited to:

• Collaborates with authors, reviewers, and approvers to ensure successful implementation of new/revised SOPs, primarily through the management of document lifecycle (new or existing documents) and review/approval workflows.

• Coordinates maintenance and periodic review of existing SOPs.

• Facilitates SOP scoping activities.

• Performs training curricula creation and maintenance, facilitates annual curricula review, creates/designs training courses, develops periodic GMP training courses, and provides systems training assignments

• Provides additional documentation and training support for client areas as needed.

• Maintains a compliant level of knowledge relative to GMP requirements.

• Provides audit and inspection support as assigned for preparation and execution activities.

• Proactively identifies opportunities for work/process improvement and efficiency.

• Represents Development Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing quality guidance as assigned.

• Assists in Quality Management System project planning activities, and other projects as assigned.

• Prioritizes activities in support of multiple projects in conjunction with management.

Education Minimum Requirement:

• Bachelor's Degree in appropriate Science, IT, Engineering or Business discipline.

Required Experience and Skills:

• Minimum 5 years’ experience in Pharmaceutical or related industry

• Experience in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, production, regulatory, research, development, supply chain, design, engineering

• Excellent verbal and written communication and presentation skills

• Good Manufacturing Practice (GMP) or related drug regulation knowledge

• Computer skills; knowledge and competency in PowerPoint, Excel, and Word

• Ability to manage multiple priorities and projects

Preferred Experience and Skills:

• Previous experience in the SOP and training quality systems and digital learning management systems

• Familiarity with Research and Development (R&D) or clinical supply areas and processes

• Collaboration and teamwork skills

• Strong leadership skills for the ability to lead cross-functional teams

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R242920