Associate Director, Quality Management System, QA

Arcus Biosciences; Hayward (CA); Sur place; USD 185 000 - 195 000; Plein temps

Avantages offerts par ce poste

Stock Programs

Performance-Based Bonus

Comprehensive Benefits Package

Résumé du poste

An established industry player is seeking a seasoned Quality Assurance professional to enhance their Quality Management System. This pivotal role involves ensuring compliance with cGMP standards while fostering a culture of quality across the organization. The successful candidate will collaborate with cross-functional teams to drive continuous improvement in quality processes, implement training programs, and provide leadership in quality management. If you are a proactive leader with extensive experience in the Pharma/Biotech sector and a passion for quality, this opportunity is perfect for you to make a significant impact in a dynamic environment.

Qualifications

• 15+ years of experience in Pharma/Biotech Quality Assurance in a GxP environment.
• Excellent knowledge of GxP requirements and regulatory guidelines.

Responsabilités

• Design and maintain the Quality Management System (QMS) to ensure compliance.
• Lead continuous improvement initiatives and training programs.

Connaissances

Quality Assurance

Regulatory Compliance

Cross-Functional Leadership

Problem Solving

Communication Skills

Organizational Skills

Interpersonal Skills

Formation

BA/BS in Biological Sciences

Equivalent Experience

Outils

Veeva Vault

Microsoft Office

Visio

Description du poste

Summary

The Quality Assurance (QA) department is seeking an experienced QA professional who will be responsible for assessing, improving and maintaining the Quality Management System (QMS). This is to ensure a state of cGMP compliance and support the effective execution of Quality Management Systems. The qualified candidate will partner with the Quality Assurance QMS, Sr. Director for continuous improvement of Quality Manual policies, procedures, work instructions and processes while also leading cross functionality to build a culture of quality.

Responsibilities

1. Design an architectural landscape for Quality Management System.
2. Assess, improve, and maintain the QMS elements including Quality Manual, policies, procedures, and controls, enabling successful and efficient processes to meet regulatory requirements.
3. Interact with quality and cross functional stakeholders on the performance of quality systems.
4. Ensure continuous improvement while keeping current with emerging and changing regulations, guidance documents, and industry best practices.
5. Provide cross functional quality leadership and act as Subject Matter expert for, at a minimum Deviation Management, CAPA & Effectiveness Check, Change Management, Document Control, Training Management, Product Complaints, Quality Management Reviews.
6. Oversee the performance and effectiveness of the Quality Management System programs as well as Quality Risk Management, Training, Documentation and Records Management, and Data Integrity.
7. Monitor the state of control of Arcus Quality Management System.
8. Evaluate and identify improvement opportunities, utilize critical thinking, and apply problem solving skills, to improve and sustain product quality and process effectiveness in the overall QMS lifecycle.
9. Establish robust and comprehensive processes to assure corrective and preventive measures are systematically implemented and controlled.
10. Lead the revision of Quality Management Systems documents.
11. Implement a training program for Arcus GxP staff to maintain compliance with regulations and internal processes and procedures.
12. Train end users of the Quality Management System.
13. Provide metrics on the performance of QMS.

Qualifications

1. BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.
2. 15+ years of Pharma/Biotech industry experience in Quality Assurance (QA) in a GxP environment.
3. Direct experience with key quality systems (e.g., Change Management, Deviations Management, CAPA and Effectiveness Check, Product Complaints, Training Management, Document Control and Quality Management Review).
4. Excellent working knowledge and understanding of GxP requirements, proficiency in applying regulatory and ICH guidelines.
5. Broad experience in the bio-pharmaceutical industry in small molecules and large molecules.
6. Experience with implementation and management of electronic quality management systems, experience with Veeva Vault is highly desired.
7. Experience developing and reporting quality metrics.
8. Excellent working knowledge of quality systems and GxP standards applicable to product life cycle from development to commercial.
9. Ability to prioritize and partner with other functions to meet deadlines efficiently.
10. Ability to provide internal training i.e. SOPs and Policies with excellent public speaking skills.
11. Proficient with the Visio, Microsoft Office software, including Word, Excel, PowerPoint experience with Project a plus.
12. Excellent verbal and written communication skills (e.g., listening skills, ability to interpret and summarize information and clear and concise communication skills).
13. Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to detail.
14. Strong interpersonal skills and the ability to assist personnel in a fast-paced environment and the ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
15. Highly ethical, self-motivated and self-directed.
16. Works effectively and independently as well as in a team environment.
17. The ability to effectively interact with internal peers and site management to lead continuous improvement.
18. Demonstrate accountability in a fast-paced environment and work independently with a high degree of flexibility.
19. Possess positive attitude, and strong interpersonal skills.
20. Ability to work effectively in a team environment with exceptional interpersonal skills, and attention to details.
21. A self-starter individual, highly motivated with high level of initiative and strategic planning.
22. Provide clear directions to internal stakeholders.
23. Possess a leadership style and not a follower in project setting and group meetings.
24. Customer Service approach.

Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.

This role will be based at our Hayward, CA location. The anticipated salary range for fully qualified candidates applying for this position is $185,000 - $195,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.

EOE

Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets

#LI-JS1