- This position is responsible for facilitating site procedural documents across areas of the QMS Framework and in association with electronic systems that support maintaining the QMS.
- This includes, but not limited, to document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, retirement and archival.
- Responsible for compliance assessment of procedural documents against Global Procedures and Policies and evolving global health authority regulations and health authority inspection observations. Write and revise document control procedures including leading the development and roll-out of document control tools.
- Maintain a contemporary knowledge of current industry trends, standards and methodologies as it relates to quality systems and document management.
- Serves as the site Subject Matter Expert for procedures and their QMS and provides cross site support for a variety of different document management systems and process.
- Identifies and supports strategic initiatives and continuous improvement projects related to QMS
- Synthesize feedback from SMEs/procedural document teams to identify and resolve issues in order to accurately document current and future processes
- Effectively manage projects, escalate issues as necessary and identify/meet key milestones
- Work with limited guidance to manage the development of site procedural documents and, seek input as needed
- Representative for global document management initiatives and projects
- Support site inspections and audits
- Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies
- Collect metrics to identify trends and take appropriate action
- Responsible for communication of procedural document status to businesses
- May be required to support updates to existing Quality Systems and implementation of additional Quality Systems.
- Act as Document Control SME and owns completion of Quality Records including CAPAs, Deviations, Change Controls, etc.
- Lead meetings and represent function at cross functional and network meetings.
- Share data/ knowledge within and across site and network. Build & maintain strong relationships with partner functions.
Qualifications & Experience
Education:
- Minimum of a bachelor s degree
- 5+ years experience in the BioPharm/Pharmaceutical industry with cross-functional experience in one or more areas (i.e. research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT)
- Experience with demonstrated knowledge in quality and/or compliance discipline with in-depth knowledge of cGMP requirements and global health authorities regulations
- In depth knowledge of cGMP requirements and global health authority regulations with ability to interpret, apply and implement.
- Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheet, etc.
- Proficiency in reviewing and processing controlled documents in an electronic document management system.
- Excellent verbal and technical writing skills with advanced ability to independently prepare written communications to management with clarity and accuracy.
- Ability to work in a fast-paced team environment and lead peers through changing priorities.
- Detail oriented and task focused with ability to meet deadlines and support work prioritization.
- Able to independently work across and influence cross-functional groups and network teams to ensure requirements are met.
- Confident in making decisions, able to anticipate Quality issues and proactively solve problems.
- Curious and ability to think critically to create innovative solutions.
- Lead Document Control Projects as needed for continuous improvement and site wide implementations.
- Strong negotiating and influencing skills in a matrixed organization.
- Demonstrated ability to work independently and mentor team members.
- Ability to identify, manage, and/or escalate issues and risks to timelines.
- Fluent in English, with proven professional working proficiency in English for reading, writing and speaking.
With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
