Technical Quality Manager

Technical Quality Manager

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Mandarin fluency (written and communication) is required to perform the job duties.

Position Summary :

The Technical Quality Manager will support Corp Quality and Regulatory Affairs. Responsible for ensuring compliance with applicable domestic and international standards and regulations are met. Serve as Quality interface with other departments and business or marketing partners to support investigation of customer complaints from China, support regulatory submissions to China, coordinate with Chinese distributor to support Grifols product release and marketing, participate cGMP inspections by Chinese Authorities and / or distributors, and collaborate with Grifols strategic partner in China to improve its quality systems. This role will independently exercise judgment based on relevant regulations and current industrial standards.

Primary Responsibilities for Role :

• Provides expertise to advise and influence the technical decisions with cross functional teams
• Proactively researches applicable international regulations and guidance and partners with regulatory affair and relevant business units to assess the impact and develop action plans as needed.
• Prepares annual reports according to Chinese regulation together with regulatory affair team and submit to Chinese authority
• Serves as Quality interface with all Grifols biopharma sites to ensure Chinese regulations and standards are met
• Reviews Customer Notifications and prepare, approve & submit data packages for external customers.
• Provides regular detailed updates to upper management regarding the current status of quality and regulatory affair related to Grifols Biopharma business in China.
• Participates in audits from Chinese regulatory bodies and customers
• Assists & makes recommendations to Grifols strategic partner in China for improvements to existing Quality systems.
• Collaborates with other departments and business partners for complaints investigations ensuring thorough and timely disclosure
• Leads meeting with stakeholders and strategic partners as appropriate
• Prepares appropriate agendas and meeting minutes. Monitors the progress of items on the meeting agendas and reports progress, as appropriate.
• Creates and / or reviews English-Chinese translations on documents. Provides verbal English-Chinese translation in meetings and other business activities.
• Reviews and assesses change control for impacts on Grifols licenses in China
• Partners with regulatory affairs to develop submission strategy to China. Reviews submission documents
• Assists all sites in preparing batch release documents to China. Coordinates with distributor in China to meet all the batch release requirements of China, and provides quality support to marketing and sales in China
• Manages quality or regulatory affairs projects that involves multiple departments / companies to meet timelines and deliverables

Knowledge, Skills, and Abilities

Strong communicator with an ability to work with stakeholders and adjust communication across different audiences Demonstrated ability to influence decision makers across multiple departments Ability to manage multiple concurrent projects with competing priorities Technical writing skills with ability to translate scientific information into technical documentation Demonstrated ability to independently make sound quality decisions Advanced knowledge of Quality system, Manufacturing processes, and regulatory affair Working knowledge of Microsoft Word, Excel, Power Point. Organizational skills, attention to detail and ability to prioritize in a fast paced environment is essential. Must demonstrate initiative, independence, balanced assertiveness, flexibility and team orientation.

Education

Requires BA or BS in a biological or chemical science or related field

Experience

5-8 years related quality experience in regulated environment Must be fluent in Mandarin (verbal, reading, writing) Experience in plasma fractionation industry is a plus

Occupational Demands

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Occasional international travel. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Works with little need for guidance or reliance on oral or written instructions from management. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

The estimated pay scale for the Technical Quality Manager role based in Los Angeles, CA, is $105,000 - $115,000 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to : Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse / family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.