Manager, Global Records

Vor 2 Tagen

Basel, Schweiz BeiGene Vollzeit

General Description:

- Responsible for ensuring that GCP records are handled and maintained to the required standards by maintaining awareness of current regulatory, legal, and other relevant guidelines.
- Deliver on the strategy for Records Management within the TMF Management group ensuring the operational aspects are handled daily.
- Oversee storage system for both electronic and existing paper documents that will allow for identification and retrieval of documents in support of the Trial Master File (TMF) records across the organization.
- Makes recommendations and ensures compliance in how records are stored, retrieved, refiled, archived, destroyed, retained with high standards and mínimal supervision.
- Acts as archivist for the Global TMF records.
- Interact with external vendors related to Records Management.
- Work with the Corporate functions to carry out the aims of Records Management, ensuring retention and legal holds are adhered to for the Global TMF records as applicable.

Essential Functions of the job:

- Manages and oversees quality within Records Information Management and associated business process, looking for improvement opportunities and relentlessly seeking to translate improvement opportunities into realities.
- Maintain Standard Operating Procedures (SOPs) and Work Instructions for job function within Records Information Management, discovering and documenting process improvements.
- Recommending the decisions for accurate Legal Hold requirements and destruction of global records based on corporate retention guidelines.
- Responsible for ensuring the compliance of deliverables to applicable regulations, guidance requirements and internal client requests for records.
- Lead awareness efforts and promote/educate employees on Records Management, associated business quality and compliance.
- Performing yearly testing of the TMF processes to ensure success during both audits and inspections.
- Work with external third parties as necessary in the execution of the Records Information Management strategy and vision.
- Ensuring compliance in how Global TMF records are stored, retrieved, refiled, retained, archived, destroyed.

Supervisory Responsibilities:

- Management of projects and ensuring resources on projects/tasks deliver on time.
- This role may have direct reports and/or contractor resources for key projects.

Education Required: Bachelor’s degree in Life Sciences, Records Management methodology, or Scientific Library

Skills/Other Qualifications:

- Experience in the pharmaceutical industry
- Working knowledge of drug laws, regulations and guidelines is essential.
- A thorough knowledge and understanding of GxP/GCP Records Management is required, including retention requirements and systems utilized in records management for the pharmaceutical industry.
- Project management experience.
- Self-sufficient, self-motivated, excellent leadership skills, able to prioritize and delegate, detail oriented, good interpersonal skills, ability to effectively communicate in writing and orally with peers and upper management.
- Advanced computer skills in MS Excel, MS Word, MS Outlook, MS Visio, MS Project, Adobe Acrobat are vital.

Travel: 10%-15%

Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse inform

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