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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.

 

Summary:

Manages the activities of the Document and Change Control Department for Grifols Bio Supplies, Develops, implements, and monitors change control processes to ensure compliance with regulations and standards, and to ensure continual process improvement.

 

 

Primary Responsibilities:

Develops, implements, and manages department processes in harmony with company goals and objectives; develops departmental goals and objectives, and directs and monitors their achievement.      Leads and manages change control process improvement initiatives (e.g., monitors key performance indicators, records management, etc.). Provides support for training initiatives as needed. Leads and manages document changes through electronic system (DCM/LSQM). Incorporate interactive tools for task assignment among team members. Hires and trains staff; provides leadership and direction with respect to duties, projects, and development.            Liaises with other departments (e.g., Training, Regulatory Compliance, Information Solutions, Purchasing, Regulatory Affairs) to ensure continual alignment and improvement of shared processes. Liaises with other business groups (e.g., collection centers, testing labs, warehouses, manufacturing sites) to achieve alignment of interrelated processes. Provides support for quality initiatives in the field, ensuring alignment with business initiatives. Represent Change Control on projects that impact quality systems and donor center operations and regulatory compliance. Provides guidance to other business functional groups regarding project plans and/or change implementation to facilitate effective and compliant change. Reports departmental key performance indicators (KPIs).                                                              

 

 

Additional Responsibilities:

Oversees the management of the change control system that manages all changes made to vendors managed by Supplier Quality, critical supplies, GMP processes and procedures. Assists with the development, implementation, monitoring and improvement of department quality systems.

 

 

Knowledge, Skills, and Abilities:

Knowledge of records management principles and practices, and current Good Manufacturing Practices (cGMP) in a regulated environment as it applies to Change Control and Document Control. Strong managerial and project management skills. Demonstrated problem-solving skills. Excellent oral and written communication skills. Ability to prioritize competing tasks and meet deadlines. Ability to analyze and interpret data, identify errors and implement effective corrective actions.  Technical expertise in document control and quality systems with strong emphasis on the conceptual understanding of overall operational process required to provide department with direction and oversite. 

 

 

Education and Experience:

Associate's degree in chemistry, biology, physical sciences or related field or Bachelor with 5 years related experience. Typically requires a minimum of 7 years of related experience in plasma collection or pharmaceutical industry. Experience with design and control of documentation and quality systems. Project or technical leadership experience required.  Supervisory or management experience preferred.

 

 

Occupational Demands:

Occupational Demands Form # 5:  Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated 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. Frequently drives to site locations with occasional travel within the United States. 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. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.             

 

Pay scale of $97,200.00 - 145,800.00 per year depending on training, education and experience. This position is eligible to participate in up to 8% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, 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, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with arrests or conviction records, in a manner consistent with the requirements of applicable state and local laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

 

Location: NORTH AMERICA : USA : Home Office:USHOME - Home Address 

 

Learn more about Grifols