Site Head Of Quality

Job Description

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals
At Microbial Manufacturing Services (MMS), a business unit of Thermo Fisher Scientific we deliver, from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative therapeutics. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
How will you make an impact?
 

Leads and manages site Quality programs and activities to support contract manufacturing organization operations. This role oversees Quality On-the-Floor, Batch Record Generation, Review, and Approval. Provides leadership, strategic thinking, and results focus to reliably meet and/or exceed the site’s production targets while achieving high levels of Quality. This position requires an individual capable of partnering across the organization to manage a fast-paced production environment and deliver exceptional service to our clients. Ensures business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines.

What will you do?

• Implements the overall quality strategy for the facility. Reports to the Director, Quality – Advanced Therapies
• Interfaces with the Operational and Quality Leadership Teams of MMS to ensure alignment with Manufacturing.
• Ensures that support functions are executing to the global quality strategy.
• Oversees Quality Control, Quality Systems, and Quality Operations departments at Carlsbad site.
• Oversight of lot disposition of Drug Substance.
• Acts as the lead SME for critical quality or compliance issues within the facility.
• Manages the budget and resources to maximize efficiency and maintain quality/compliance at high levels.
• Develops, directs, and maintains quality systems in support of manufacturing in a manner consistent with global quality systems requirements, corporate standards and current regulatory requirements, and others as needed. Quality systems include but are not limited to: audits and inspections, documentation and records management.
• Oversees all aspects of QA Operations within the facility, including but not limited to executed batch record review, on the floor QA support, material release, deviation investigations, change controls, customer quality support and SOP and master batch record review.
• Oversees QC Micro and QC Analytical teams. Ensures compliance with all site, corporate and global regulations.
• Develops QC staff to reach full potential by setting goals, developing personnel and managing performance.
• Responsible for release of bulk drug substance and drug product batches.
• Ensures QA support for internal and external project and team meetings.
• Provides leadership and management for the quality function and sustains the quality philosophy and lean culture at plant level.
• Establishes, maintains and optimizes an effective quality management system.
• Has decision-making authority for any Quality issues; informs Director, Quality - ATx of critical issues in a timely manner. Builds and maintains expertise in the QA Operations team, including development of staff. Applies biologics manufacturing experience to ensure that operations meet customer and regulatory expectations and requirements for manufacturing at all phases of product development.
• Communicates customer, regulatory and organizational requirements to assure product quality, contract compliance and customer satisfaction.
• Coordinates necessary plant personnel for internal, customer and third-party quality system audits.
• Maintains a corrective action system to analyze and correct nonconforming conditions and complaints.
• Implements the performance measurements necessary to effectively evaluate organizational performance and trends in product quality, services, customer satisfaction and the cost of poor quality.
• Uses the results of performance evaluation to target improvement efforts.
• Performs other duties as assigned.

How will you get here?
Education

• BS in Biology, Chemistry, or other closely related life sciences field

Experience

• At least 9-10 years of related experience in the Quality field.
• At least 5 years of prior supervisory experience required.
• Extensive exposure to cGMP environment.
• Strong organizational and time management skills. Prioritization and problem-solving skills.
• Strong knowledge of Quality procedures, processes and guidelines. Recognized by colleagues as a source of expertise.
• Experience leading conversations with customers (internal and external).
• Strong interpersonal and communications skills; written and oral.
• Understanding of applicable regulatory requirements.

Knowledge, Skills, Abilities

• Ability to write reports, business correspondence and procedures
• Strong organizational skills; ability to prioritize and manage through complex processes/projects
• Ability to read, analyze and interpret business periodicals, common scientific, professional and technical journals, financial reports, governmental regulations and legal documents
• Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community
• Ability to define problems, collect data, establish facts and draw valid conclusions
• Excellent communication skills
• Ability to multitask, strategically and tactically
• Excellent knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals.
• Ability to apply GMP regulations and international guidelines to all aspects of the position
• Ability to travel up to 20%

Benefits:

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

EEO/Reasonable Accommodation:

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Compensation and Benefits

The salary range estimated for this position based in California is $130,000.00–$195,000.00.

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-rewards