Sr. Manager, Quality Systems Compliance
Location: Redwood City, CA
This role is responsible for assuring compliance to cGMP and other applicable regulatory requirements for phase appropriate GMP manufacture of Rezolute products. Responsibilities include leadership and implementation of electronic quality management platforms and maintenance of the Quality Management Systems. This is a key quality contributing role reporting to the Director, Quality Compliance.
Principle Duties and Responsibilities Include:
- Provide leadership and program management support for the Quality Systems.
- Application of phase appropriate controls to systems and requirements.
- Lead and implement validated electronic solutions for Quality Systems.
- Familiar with Computer System Validation (CSV) requirements and documentation.
- Establish and ensure compliance with document management standards and procedures including adherence to document tagging practices and electronic repository structure.
- Lead effort for load of all documentation into Veeva platform from historical sharepoint and remote storage locations.
- Facilitate the process of creating, reviewing, approving, and archiving all controlled documentation.
- Assign and track training requirements for all employees engaged in GXP activities.
- Maintain system documents related to the corporate Training System and training records
- Implement Data Integrity practices and procedures to meet regulatory requirements.
- Ensure project requirements are established and completed within a defined timeframe.
- Leadership of cross-functional project teams (managing scope, deliverables, timelines, and team members).
- Must be able to work with other technical groups to resolve issues, close gaps and seek quality compliant outcomes which are efficient and robust.
- Responsible for the authoring (technical writer) or review and approval of controlled documentation including Standard Operating Procedures (SOPs), work Instructions, forms, specifications, and user requirements.
- Provides leadership for employee relations through effective communications, coaching, training and development and eliminate roadblocks for the team to move forward.
- Must be able to effectively communicate to management Quality issues that arise inside systems.
- Responsible to make fact-based, scientifically and/or statistically sound, quality / regulatory compliant decisions.
- Develop and coordinate reports/scorecard/metrics for measurement of the programs.
- The Senior Manager will provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance.
- Must be thoroughly knowledgeable with pharmaceutical cGxP requirements including strong working knowledge of FDA and EU requirements / guidance documents.
- Responsible for the authoring or review and approval of investigations, CAPAs and change controls to drive for resolution through root cause analysis.
- Support of Change Control Review Board
- QA lead/support for preparation and hosting regulatory inspections with document retrieval function, inspection logistics oversight; other functions as required.
- Supports internal and external audits as needed.
- Proactively identify and implement items to enhance quality through continuous improvement.
- Conduct training in QMS topics
- Ability to work remotely and adjust to changing priorities and unforeseen events.
- Bachelor’s degree in a technical or related field
- Equivalent combinations of education, training, and relevant work experience may be considered
- 10 + years progressive experience in the pharmaceutical industry or related industry
- Demonstrates advanced knowledge in Quality Compliance and Quality Systems
- 5 + years experience leading mid-large organizations
- Demonstrates knowledge of GxP
- Demonstrates leadership skills
- Excellent organizational skills
- Excellent verbal and written communication skills
- Technical Writer
- Proficient with the English language
- Ability to drive functional, technical and operational excellence
- Ability to inspire and foster innovation, collaboration, transparency and team effectiveness
- Proven successful management of people and projects
- Good interpersonal and communication skills (both oral and written)
Preferred Experience, Special Skills and Knowledge:
- Software Program Proficiency (Veeva platforms, learning management systems, Quality Systems deviation, change control, CAPA, Regulatory).
- Technical writing
- Strong analytical skills. The ability to systematically gather information from a variety of sources, analyze information, identify implications of data, draw appropriate conclusions, generate viable alternative solutions to a question or problem and have the ability to apply Quality Risk Management processes to evaluate the consequences of choosing each alternative.
- Drive results by documenting results of conversations and apply methods for follow up.
- Self-motivated, self-disciplined, and able to function remotely.
- Exceptional organizational skills and attention to details
- Strong collaboration skills and ability to prioritize, multi-task, and work in an evolving environment.
- Computer proficiency (MS Word, Excel, PowerPoint).
Interested and qualified candidates should send their resume to firstname.lastname@example.org to the attention of Human Resources.
Rezolute (RZLT) currently anticipates the base salary for the Sr. Manager, Quality Systems Compliance role could range from $150,000 to $170,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.
Qualifying employees are eligible to participate in benefit programs such as:
- Health Insurance (Medical / Dental / Vision)
- Disability, Life & Long-Term Care Insurance
- Holiday Pay
- Tracking Free Vacation Program
- 401(k) Plan Match
- Educational Assistance Benefit
- Fitness Center Reimbursement
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.