15 jobs found in Oklahoma City, OK

Within this role you will be responsible for working with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Regeneron IOPS and to build inspection readiness capability across the organization. This role will help to build mechanisms within the business to educate on compliance awareness and ensure we are performing in a compliant manner. The Director will also provide support during regulatory inspections and internal audits and work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes. As Director of GMP Compliance & Inspections a typical day may include, but is not limited to, the following:   Utilizing strong critical thinking skills to serve as a thought partner to the GMP Compliance and Inspections leadership with regard to complex problems Leading proactive evaluation and education of site GMP compliance against current and emerging...

Within this role you will support the Process Sciences laboratory operations by supporting adherence to site policies and procedures associated with but not limited to good documentation practices, data integrity considerations, equipment and vendor maintenance and PS study execution, recording and reporting. As a Compliance Specialist within Process Sciences, a typical day might include, but is not limited to, the following:   Ensuring oversight and support for PS laboratory operations comply with site data integrity policies and procedures. participating in ATRAs, audit trails reviews, data recording, storage, and verification Maintaining laboratory records in accordance with site procedures is essential. Types of records include paper and electronic lab notebooks, laboratory logbooks, equipment maintenance records, and laboratory study protocols and reports Completing quality records such as deviations, CAPAs, and change controls with support and oversight...

The successful candidate will manage and support the external testing activities within the Quality Control group in support of the company’s quality program. A typical day might include, but is not limited to, the following: Organizing and scheduling external testing to support product release/stability testing under cGMP Managing external data review per production schedule and stability program Performing the single point of contact role with contract laboratory facilities Evaluating and monitoring the performance of the contract labs Coordinating investigation activities at contract laboratories to ensure thorough technical content and compliant documentation Communicating and soliciting input from Regeneron SME’s and Quality Assurance Coordinating the issuance and approval of Quality Agreements with contract labs Authoring Master service Agreements, as necessary Participating in GMP audits to the contract labs Coordinating and leading quarterly meetings...

The HCP Contracting Manager will facilitate the contracting process for oncology international activities for Regeneron. This role encompasses overseeing the end to end process of HCP contracting and sponsorship activities.   what a typical day might look like: Oversee the complete contracting process with members of the healthcare community and sponsorships across multiple geographies. Serve as the primary point of contact for guidance and support on contracting processes. Provide training on processes and develop and maintain resources, web pages, training materials, and quick reference guides. Manage relationships with key internal stakeholders, including Medical Teams, Compliance Officers, Legal Counsel, Finance, and Commercial Operations. Stay informed about company policies, procedures, and government regulations related to HCP Contracting and Sponsorships. Proactively develop and provide timely resolution to issues Participate in...

The Sourcing Specialist will be responsible to support assigned categories and is a proven collaborator who can work with cross functional teams across Regeneron, locally, regionally and internationally. Essential Duties and Responsibilities include, but are not limited to, the following: Being accountable for supporting the definition and implementation of the assigned categories strategy to serve global and regional business needs as assigned. Working closely with stakeholders to support discussions related to the assigned categories and aligns category priorities with Procurement management and stakeholders. Supporting negotiations, supplier management activities, and stakeholder engagement activities for the Categories as assigned. Taking direction to drive value in terms of cost savings, cash flow improvement, and other efficiency savings from category management activities. Supporting Global Procurement by participating in organizational decisions in the...

The Senior Manager, Global Procurement – Supplier Quality Compliance will be responsible for leading a small team of Global Procurement Compliance professionals that support and maintain all cGMP compliance aspects of procurement operations. The major activities include but are not limited to the following: management and facilitation of the Approved Supplier List (ASL), deviation investigations, CAPAs, supplier audit closures and evidence follow up, support of regulatory inspections, SOP writing and revision, change controls, and the management of the development of a Supplier Corrective Action Report (SCAR) management process via the compliance function. A typical day may include: Tracks progress on all Global Procurement quality system deliverables, including deviation investigations, CAPAs and change controls, ensuring quality and accuracy of documentation as well as adherence to established due dates Interfaces regularly with Quality Assurance and...

The Medical Affairs HCP Engagement Temp will provide project management support for international markets on HCP Engagements and sponsorships. This position reports to the Sr. Manager of Medical Affairs Business Operations. What a typical day may look like; Coordinate the complete contracting process for members of the healthcare community within international countries. Serve as the primary point of contact for medical teams seeking mentorship and support on contracting processes related to HCP engagements and sponsorships. Provide training on processes to relevant teams and collaborate with the Sr. Manager to develop and maintain resources, web pages, training materials, and quick reference guides. Stay informed about company policies, procedures, and government regulations related to HCP engagements and sponsorships.  Conducting regular reviews and supporting internal audits. Handle relationships with key internal stakeholders, including...

This is a leadership role providing Quality and Compliance oversight of site operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. As a Associate Manager Quality Compliance , a typical day might include, but is not limited to, the following:   Ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities and materials management Overseeing site quality systems including but not limited to; Deviations, CAPA, Change Control, Audits (Internal and External) and Customer Complaints Being responsible for review and approval of the following types of documents, relating to area functions: failure investigations, change control documents, corrective/preventative action documents, standard...

Within this role you will support and maintain all cGMP compliance aspects of Strategic Sourcing & Procurement (SS&P) operations under the direction and guidance of sourcing management. You'll ensure organization and timely completion of Approved Supplier List documentation in addition to process deviations assigned to sourcing (CAPAs, NOEs, EOEs) and support closure of QA Audits related to audits of raw material manufacturers and distributers. This is a 12-month temporary contract position. As a Compliance Specialist, a typical day might include, but is not limited to, the following:   Supporting and proactively maintaining all procurement cGMP procedures, documentation and training related to SOP and Work Instructions Maintaining and managing the Approved Supplier List (ASL) Addressing compliance needs and coordinating with other sites to ensure engagement, feedback and buy in related to procurement document revisions Driving successful...

In this role you will be responsible for fostering a culture of data governance (DG) within the site by ensu r ing compliance with Data Governance policies ; designing and delivering relevant training ; and monitoring Data Governance practices. The role is pivotal in promoting data stewardship, enhancing data quality and ensuring the principles are embedded in the site culture.   In this role, a typical day might include the following: Work ing in conjunction with the Global DG (Policy & Programs) t eam to d esign and deliver c ontinuous DG Training in line with current and evolving required DG knowledge, skills and awareness needs . This includes:   Designing and developing comprehensive training programs focused on DG , compliance with regulations, and best practices for bio- pharmaceutical manufacturing   Conduct training needs assessments to identify training gaps and areas...

In this role you will act as a bridge between global policy and standard setting and the local implementation of these within the site business unit(s). Your role will play a fundamental par t in safeguarding the quality and reliability of the organisation’s data which is essential for informed decision making and regulatory compliance. In this role, a typical day might include the following: Successful building, leading and managing of the site Data Operations &  Engagement, C ulture & Monitoring (ECM) t eam Successful delivery/implementation of site data governance (DG) responsibilities and standards   Responsible for successful stakeholder engagement and management across the site   Responsible for establishing a successful relationship with the global Governance Team (Policies & Programs) so a clear feedback loop is established     Responsible for the...

In this role you will play a pivotal part in ensuring that Regeneron’s Data Governance (DG) systems and practices meet the highest standards of regulatory and industry compliance. You will be r esponsible for providing specialised knowledge and expertise in the design of ( DG) frameworks, policies and procedures that are aligned with regulatory requirements and industry standards.   In this role, a typical day might include the following: Assessing current and evolving regulatory guidance and industrial intelligence in relation to IOPS business practices   Subject Matter Expert (SME) for authoring and developing the standards, policies and procedures in line with regulatory requirements and industry best practices   Technical writing, research and related editing activities , ensuring accuracy and consistency of documentation and that the appropriate approvals are received   Generating and...

Within this role you will be responsible for initiating, leading and executing compliance related activities, such as investigations, change controls, CAPA, etc. across all areas within Supply Chain Management. As a Supply Compliance Senior / Analyst, a typical day might include, but is not limited to, the following: Developing an effective compliance framework for all Supply Chain departments through the development and implementation of appropriate compliance related policies and procedures Acting as a liaison between the Supply Chain departments and onsite quality and regulatory groups to define and address all issues of non-compliance Facilitating all reviews and revisions of all Supply Chain department related SOPs, plans and policies for each group within the department Providing support, information and assistance to individual groups and supervisors with the initiation, review, submission and follow-up of documents such as CCs, NOEs, DNFs, impact statements...

This leadership role is fundamental in creating, building & motivating a global Data Governance (DG) team responsible for maintaining compliance with regulatory standards. It offers an opportunity to shape the DG landscape of Regeneron, driving innovation and excellence through data. The role will suit a visionary leader with a passion for data and a track record for driving success. The post-holder will set and implement a strategic vision for Regeneron’s data maturity roadmap including policies & procedures.   They will lead the required change management program to enable the creation and embedding of a sustainable data quality culture across the organization.   They will also be accountable for the Regeneron Industrial Operations and Product Supply (IOPS) DG program & serve as the global leader and subject matter expert on DG practices. In this role, a typical day might include the following: The creation & delivery of IOPS’ DG Program (Strategy,...

This role supports and maintains compliance of QA Operational Team, inclusive of but not limited to QA Operations; Document Control; QA Raw Materials and QA Systems with mandated regulatory requirements and site expectations. As a QA Specialist/ Sr QA Specialist a typical day might include, but is not limited to, the following:   Maintaining regulatory compliance in accordance with current Good Manufacturing Practices (cGMP). Collaborating with Cross functional teams to resolve issues, complete investigations and maintain compliance. Reviewing and approving of the following types of documents: Failure investigations associated with deviations, Corrective and preventative actions (CAPA), Standard operating procedures (SOP’s), GxP documents & Change control documents. Supporting root cause analysis ensuring appropriate CAPA are implemented to prevent recurrence where relevant as a quality approver. Reviewing procedures, policies and other...