620 E Grand Avenue South San Francisco, CA 94080 | Contract
Bayside Solutions is seeking a Process Manager to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Work closely with the business to identify and analyze core business processes and workflows to improve the processes and identify opportunities and potential solutions on a variety of process and quality improvement projects and activities.
- Responsible for analyzing, refining and developing processes through implementation and will contribute to the ongoing programmatic effort to build or refine effective global and cross-functional controlled documents (including policies, procedures, templates and forms) in a manner conducive to the business.
- Serve as a change agent for; disseminating information, driving standardization and collaboration, resolving issues, and assisting teams with effectively implementing process improvements internally and externally as project impacts dictate.
- Organize and facilitate teams to critically review current processes for effectiveness, quality and simplification and identify implementation requirements requiring cooperation and support from cross functional stakeholders/business partners; establishing links between business strategy needs and process improvement initiatives.
- Elicit requirements using interviews, document analysis, requirements workshops, surveys, site visits, business process descriptions, use cases, scenarios, business analysis, tasks and workflow analysis.
- Develop procedural documents, including process maps, working documents and clinical study manuals in compliance with regulatory requirements and global processes.
- Collaborate with PTM, gRED subject matter experts and business partners to ensure appropriate documentation and controlled document requirements are identified and integrated in process maps (business requirements).
- Routinely prepare reports by collecting, analyzing, and summarizing information as required.
- Regularly attend PTM and cross functional staff meetings to present project and process improvement activity status.
- Serve as internal advisor to address process related questions from personnel and gather information to distinguish requests from true business needs.
- Develop tools, templates and procedural documents to support the tactical application of business processes as required.
- Routinely solicit feedback from users on process enhancements, training and other means of driving more effective utilization and systems and process integration.
- Provide input to training programs and team effort by accomplishing related results as needed.
Summary of Qualifications:
- Bachelor’ s degree and a minimum of 8 years of experience working in pharmaceutical or healthcare related industry or 6-9 years with Master (E4 level).
- Minimum 3-5 years of experience as a Process/Business Analyst or equivalent.
- Knowledge of the drug development process, GCP/ICH requirements highly desired.
- Advanced understanding of the Microsoft Office Suite; proficient in use of MS Word, Excel and Power Point.
- Must have demonstrable ability to learn new systems and develop procedures to support new systems.
- Past experience working with FDA or a regulated environment.
- Understanding of GCP, ICH and core document management practices.
- BPM and/or Six Sigma certification.
- PMP or quality processes certification Competencies Identified for Success.
- Strong skills in process mapping and business process re-engineering.
- Strong analytical skills with a demonstrated ability to extensively analyze business processes and workflows.
- Experience facilitating workshops and focus groups.
- Experience developing business requirements.
- Experience developing procedural documentation and presentations.
- High level of competence with MS Office and MS Visio.
- Ability to: influence with or without authority, facilitate groups with diverse perspectives, and bring teams to consensus/alignment.
- Adept in critical thinking with demonstrated analytical, problem solving skills.
- Excellent planning and prioritization skills with ability to multitask and adapt in a fast-paced environment.
- Able to synthesize large amounts of information.
- Able to deliver results despite shifting environment.
- Excellent verbal and written communication skills and the ability to interact professionally with a diverse group, executives, managers, and subject matter experts.
- Detail oriented with the ability to work independently and prioritize multiple tasks efficiently.
- Strong project management skills.