QA Manager

Job DescriptionAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.Location/ Division Specific InformationThe Biosciences Division (BID) offers reagents, instruments, and consumables from across the division’s six business units. This division is truly grounded in science with our products offering new hope to cancer patients and so much more. BID is a $2.5 billion business with 4,000+ employees across the globe. Our team serves 480,000 customers with 70,000 products in 180 countries.How will you make an impact?Provide direction and management to the functions within Quality Systems & Compliance : investigations, CAPAs, Metrics & Trend Reports, Quality Agreements and Audits. Define, structure, and implement Quality Systems in accordance with GMP and Corporate Quality Standards & Guidelines. Mentor the team to create a culture of quality awareness, teamwork, compliance, and continuous improvement with a focus on strong cross functional service throughout the site. Identify and implement tools and processes to drive compliance and sustained performance of the Quality System.What will you do?

Lead team responsible for Investigations, CAPAs, Change Control, Document Control, Metrics & Trend Reports, Quality Agreements, and some Release Functions e.g., C of As.

Mentor the Quality Systems team to create a culture of quality awareness, teamwork, compliance, and continuous improvement with a focus on strong cross functional service throughout the site.

Establish a team environment driven with integrity to apply quality requirements to applicable activities.

Oversee and drive the performance of Quality Systems initiatives

Monitor performance of Investigations, CAPAs, and Change Control records through identification, monitoring, trending, and reporting of key performance indicators.

Drive continuous improvement of each system, adoption of standard methodologies, application of consistency across the site, and ensure integrity of system in compliance with Regulatory, ISO9001, Corporate, and Site requirements.

Create and deliver training in support of implementing Quality Systems related enhancements to ensure adherence to requirements in support of compliance and improved performance.

Ensure Quality Systems related procedures are aligned and maintained to meet all applicable regulations, Corporate Quality Standards and Guidelines.

Attend client meetings as Quality Systems representative to provide guidance and strategic approach when required.

Host and facilitate daily huddles and weekly review boards in support of driving the performance of Quality Systems.

Ensure timely issuance of Trend Reports to proactively identify trends and have action plans in place to address them.

Host site Corporate Audits and Client Audits, ensure information to auditors is provided in a timely, accurate and complete manner during inspections.

Lead and implement internal audit program.

Be the Site System Owner for systems used at the site (i.e. support troubleshooting, provide support to end users).

Communicate issues that potentially affect product quality/compliance to the attention of Leadership.

Support the GMP and ISO 9001 Quality Unit assigned.

How will you get here?Education:

Minimum required education: Bachelor of Science in Biological Sciences, Biochemistry, Biotechnology, Microbiology, or Biomedical Engineering or other applicable Science.

Experience with biological manufacturing processes.

Project Management advanced experience preferred.

Experience:

6+ years shown experience in a Quality position within minimum ISO 9001 environment required. (Pharmaceutical Industry experience is a plus).

3+ years supervisory/ people leadership experience required.

Experience with ISO 9001 and compliance (21 CFR Part 11, FDA 21 CFR Part 820) required.

Experience with biological manufacturing processes preferred.

Project Management advanced experience preferred.

Knowledge, Skills, and Abilities:

Proven understanding of Quality procedures, processes, and guidelines.

Experience leading conversations with customers and auditors.

Ability to analyze data, summarize results, present data and address feedback.

Strong interpersonal and communication skills; written and oral. Ability for technical writing a must.

Leadership, delegation, and motivation skills to affect performance and development of individuals in the Quality Systems team and throughout the Quality department.

Highly motivated with strong organizational skills.

Ability to manage and prioritize multiple tasks and meet timelines.

Self-starter and able to work efficiently and independently and to troubleshoot and solve problems.

Ability to drive functional technical and operational excellence.

Ability to think strategically with the ability to direct the resolution of technical problems using innovative approaches.

Solid understanding of data integrity and principles of ALCOA.

Diligent and accurate while maintaining a vision of the end result.

Work with diverse teams, guide them through decision making, facilitate agreement, build collaborative relationships and focus on customer needs.

Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.

Highly skilled in Quality tools e.g. FMEA, Risk Analysis, Root Cause Analysis.

Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Trackwise, LIMS, Master Control, ERP, etc.).

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.Compensation and BenefitsThe salary range estimated for this position based in California is $103,100.00-$154,700.00.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewardsThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.