Senior Manager Quality Assurance Lead
3 hours ago
At BioSpace, Inc., we're committed to serving patients with serious illnesses. Our mission drives everything we do, and we're looking for talented individuals to join our team.
We've been a leader in the biotech industry since 1980, pioneering innovative treatments for some of the world's toughest diseases. With a focus on four therapeutic areas - Oncology, Inflammation, General Medicine, and Rare Disease - we reach millions of patients each year. As a member of our team, you'll play a critical role in helping us research, manufacture, and deliver life-changing medicines.
Our award-winning culture is collaborative, innovative, and science-driven. If you're passionate about challenges and opportunities, you'll thrive in our dynamic environment. Join us and make a lasting impact on patients' lives while advancing your career.
Job Summary
The Senior Manager Site Quality Operations (SQO) will effectively manage the daily work of direct reports responsible for quality oversight of sitewide support functions for the Thousand Oaks site. This includes incoming QA for raw materials and components, as well as a small group of Quality Management System (QMS) Specialists. The Senior Manager SQO will be responsible for advancing quality systems, overseeing incoming material batch record review and release, IQA investigations, and change controls.
Key Responsibilities:
- Ensure facilities, equipment, materials, organization, processes, procedures, and products align with cGMP practices and other applicable regulations.
- Stay up-to-date with emerging trends and regulatory advances in incoming raw materials and components.
- Ensure reliable, discerning, and timely quality disposition of raw materials and components, and Amgen transferred shipments of cell bank, drug substance, drug product, and finished drug product.
- Ensure QMS processes are appropriately designed, implemented, and managed across the ATO site to ensure they're fit for purpose for effective phase-appropriate practices in Process Development, Clinical, and Commercial functions.
- Ensure QMS site process owners maintain voice of customer engagement with process end-users, along with maintenance and execution of an annual site Quality Process improvement plan describing continuous improvement and productivity initiatives, programs, and projects based on execution performance.
- Ensure quality processes in scope are monitored, and a process health summary is provided to site leadership on a routine basis.
- Ensure appropriate staff development and training in areas of responsibility.
- Perform review, approval, and tracking of cGMP processes, procedures, and records, including but not limited to Deviations, CAPAs, change controls, and validation records.
- Champion Continuous Improvement initiatives, programs, and projects.
- Ensure changes that could potentially impact product quality are assessed according to procedures.
- Ensure deviations from established procedures are investigated and documented.
- Ensure IQA records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Ensure GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks.
- Collaborate cross-functionally and across the Amgen Enterprise/Network to ensure the Quality Management System processes are implemented, maintained, and performed in accordance with established procedures and applicable regulations. Partner with other Amgen sites in the network to ensure consistency and continuous improvement.
- Ensure appropriate escalation of key QMS risks and accomplishments to senior management, through Management Review.
- Lead inspection readiness activities for the areas.
- Participate in Amgen internal/external audits and inspections, potentially interacting directly with regulatory and/or third-party auditors.
We value diversity and inclusion, and we're committed to creating an environment where everyone can thrive. The ideal candidate will have a strong background in quality assurance, with experience in managing people and leading teams. You'll be a strategic thinker, with excellent communication and interpersonal skills. If you're passionate about quality and committed to excellence, we want to hear from you.
Basic Qualifications:
- Doctorate degree and 2 years of quality assurance experience OR
- Masters degree and 6 years of quality assurance experience OR
- Bachelors degree and 8 years of quality assurance experience OR
- Associates degree and 10 years of quality assurance experience OR
- High school diploma/GED and 12 years of quality assurance experience
Preferred Qualifications:
- 5+ years of Quality experience
- 2+ years of Management at a senior quality level
- Experience interacting with multiple sites
- Working/detailed knowledge of GMPs and global QA requirements as related to aseptic processing in US and multiple jurisdictions
- Strong leadership capabilities and proven experience applying GMP requirements in an operational setting
- Highly effective verbal and written communication skills with strong interpersonal skills
- Strong level of analytical skills to evaluate and interpret information to arrive at logical and quality-minded conclusions balanced with a willingness to take informed and appropriate risks.
- Computer Skills: Microsoft Excel, Word, PowerPoint, Project, Access, and Visio; Adobe Acrobat; database-related platforms; knowledge of Electronic Document Management System (EDMS)
- Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes.
- Ability to plan, monitor, and control a set of projects, ensuring efficient utilization of resources to achieve program objectives.
- Good organizational skills, effective project and time management skills, and ability to work well under pressure.
- Innovative approach with aptitude for developing ideas into actionable objectives.
- Direct experience driving process improvements. Working knowledge of Lean and Six Sigma methodologies a plus.
We're committed to supporting your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models, including remote and hybrid work arrangements, where possible.
Join us and make a lasting impact on patients' lives while advancing your career.
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