QA Interim Manager
6701 Kaiser Drive Fremont, CA 94555
Bayside Solutions is seeking a QA Interim Manager to be part of our client’ s team in Fremont. 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.
QA Interim Manager:
- 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:
- Plans and manages the work of the BI Fremont Quality Assurance group overseeing Quality Control.
- Provides technical expertise on Quality Assurance standards.
- Identifies deviations from SOPs in Quality Control operations; records and reports issues to appropriate parties; recommends corrective action and follows up to ensure resolution.
- Supports QA Disposition by review and approval of QC disposition elements (test record reviews, CofA approval, CofC, EM assessments etc.).
- Review and approval of QC Standard Operating Procedures and Change Controls to ensure compliance with cGMP requirements.
- Review and approval of method transfers, method qualifications and QC protocols.
- Oversight and approval of OOX investigations.
- Support Data Integrity initiatives at the site.
- Proposes and executes process and procedural changes to improve QA process performance, robustness, and efficiency (this may include any of the quality systems within the plant (for example: Document Review, Deviations, CAPA, Change Management, Training, Lot Disposition)).
- Understanding and appreciation for regulatory requirements and quality and compliance standards under which the Fremont site is operating.
- Requires strong interfaces with all functions in Fremont.
- Key functions are Manufacturing, E&T, Process Science, and Quality.
- Needs to collaborate with both the Biberach and Vienna sites for best practice sharing.
- Exposure to and dialogue with various colleagues and customers within company, particularly in the quality and manufacturing functions.
Summary of Qualifications:
- Bachelor’ s degree with plus 5 years of quality experience in a cGMP pharmaceutical manufacturing environment.
- Minimum of 3 years of experience managing/directing people.
- Expertise in Standard Operating Procedures, Good Manufacturing Practices, Food and Drug Administration, and other national and international regulatory requirements related to quality testing.
- Demonstrates ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
- Overall understanding of Quality Assurance specifications and process.
- In-depth understanding of QC/Pharma Business.
- Strong team leadership skills.
- Ability to communicate in an open, customer-focused manner.
- Ability to influence in a team environment and collaborate with peers.
- Performance focused, persistent, sound decision-making, open minded, innovative/creative and results oriented.
- Ability to interpret and relate Quality standards for implementation and review to functional areas.
- Ability to work effectively on problems of diverse scope, with analysis/evaluation of data.
- High level of personal motivation and initiative, and ability to work independently on projects.
- Attention to detail, safety, quality and customer requirements.
- Proficiency with MS Office products (specifically Word, Outlook, Powerpoint and Excel).