Manager, Quality Assurance Documentation

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.

Job Summary:

The QA Manager is responsible for managing QA Documentation Department and systems. QA Documentation Manager responsibilities include: Change Control Management and Document Management System. Ensures that all changes to documents, facility computer and packaging components are properly documented, justified and approved.  Manage/supervise QA staff and ensure their growth/development through effective performance counseling and training.

Essential Job Duties:  

• Oversees and provides direction in the maintenance of the change control system and Document management system.

Reviews all change requests for clarity, purpose, justification and Regulatory requirements

• Prepares information for annual reportable changes to be submitted to FDA
• Routine reporting of document workflow status and upcoming/overdue procedures for periodic review
• Evaluate and implement process and system improvement                                                 
• Site representative as system owner for groups consisting of various Grifols sites for benchmarking and harmonization efforts 
• Ensures that product impacted by change is placed on hold
• Responsible for design, development, revision of packaging and labeling
• Maintains effective communication with management
• Manages operational budget
• Chairs all change boards.
• Give guidance and support to production on cGMP compliance
• Provides support, direction and coaching to subordinate employees in the areas of the QA department
• Participates in regulatory and internal inspections/ audits including providing written responses as applicable for area of responsibility.

Job Requirements:

• BS degree in Biology, Chemistry, related Science or Engineering
• 5-8 years of experience in Quality Assurance and 3-5 years working in pharmaceuticals
• Supervisory experience
• Knowledge of Regulatory requirements
• Strong analytical, organizational and interpersonal skills
• Extensive knowledge of cGMPs as specified in the CFR/USP and EP Pharmacopeia / ICH and ISO Guidelines.
• Excellent written/verbal/leadership skills
• Must be able lift, push or pull 50lbs

 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 and stands. Occasionally bends and twists neck.  Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences.  Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

The estimated pay scale for Manager, Quality Assurance Documentation role based in California, is $120,000-$135,000 per year . Additionally, the position is eligible to participate in up to 15% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and 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!

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

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.

California Personnel Privacy Policy and Notice at Collection

Location: NORTH AMERICA : USA : CA-Los Angeles:USVALLEY - Valley Bl Mfg Plant - LA, CA

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