Quality Manager II
South San Francisco, CA 94080 | Contract
Bayside Solutions is seeking a Quality Manager II to be part of our Client’ s team in South San Francisco. This is an opportunity to work with a local Biotechnical company focusing on the discovery, development, manufacturing and commercialization of medicines to treat patients with serious or life-threatening medical conditions.
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 atwww.baysidesolutions.com.
Quality Manager II
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- 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:
- Provides global strategic direction and input for ensuring compliance to SDD to ensure the company meets current and future business needs.
- In collaboration with GPO, Define and track key milestones and deliverables ensuring delivery on the strategy and tactics for SDD
- Develop communication plan for SDD in conjunction with the global Process owner
- Work with key internal and external partners to develop future strategies and through strong collaboration build and maintain communication networks with key external stakeholders
- Effectively represent internal and external stakeholders on oversight committees (e.g. Steering Committees, Advisory Boards, QATs) and other cross-functional working groups to ensure that the SDD procedures remains in alignment with other global procedures.
- Establish analytics and metrics to ensure SDD procedures will withstand regulatory scrutiny
- Operational Support: Support the functions to ensure compliance SDD during the clinical trial
- CAPA Management: Support study teams and affiliates in preparation for Inspections and audits
- SME for questions on SDD during inspections
- Conduct root cause analysis for all major and critical findings
- CAPA Implementation lead role for SDD specific issues
- Identify Affiliate Management training needs and develop/implement training strategies/ interventions for their area of expertise in conjunction with internal and external functional and/or training groups and in alignment with other functions as required.
- Develop and execute a quality control (QC) plan to determine if end user adoption and consistent implementation of processes and procedures for their area of expertise have been achieved.
- Lead and/or participate in activities and knowledge sharing in their area of expertise to improve and maintain the quality of training and development.
- Support Global Procedural documents and related process documents, manage SDD wiki, manage training strategy.
- SME for questions and primary point of contact for issue escalation
- Possible Travel.
- Minimum of four (4) year University degree preferable Life Science field
- Minimum of 5 years of experience with Global Operational teams and at least three (3) years Manager experience (preferred)
- Minimum of 10 years of experience in Clinical Operations, drug safety, or regulatory
- Minimum of 5 years working in Global operational teams
- Experience in process management methodology
- Demonstrated high level of initiative and ability to function independently with minimal or no daily supervision.
- Expert knowledge of ICH/GCP, EMA, Global procedural documents and local regulatory requirements.
- Broad current knowledge of clinical development processes, roles and responsibilities
- Strong, dynamic leadership or management experience (including study or project management) with consistent delivery against commitments and goals
- Strategic and forward thinking, creative in solution development, independent decision making, prioritization, and managing multiple tasks abilities - able to make sound, timely decisions within areas of own responsibility and recognizes when and how other stakeholders need to be involved.
- Communicates effectively with credibility and confidence to present clear messages from complex information/data to all levels in the organization.
- Ability to influence a variety of stakeholders, external parties and colleagues, at a range of levels in the organization.
- Able to choose and deploy a broad range of influencing strategies. Strong customer focus.
- Leading Innovation & Change / Innovate, learn and change.