Routine management & coordination of GMP compliance systems and policies for cGMP compliant facilities.Â
Review and approval of Quality Systems which include deviations and CAPA as well as supporting disposition as appropriate.Â
Collaborates with multiple departments to ensure appropriate RCA and CAPAs have been identified.Â
Monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction.Â
Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.Â
Examines programs to create efficiencies in practices and optimal utilization of staff. Â Review of production records for compliance. Â
Assures cGMP's and company procedures are followed and, if needed, procedures/policies are revised.Â
Accountable for meeting functional area goals and objectives as they relate to departmental and company-wide goals.Â
Responsible for adhering to GMP regulations, cGMP's, company policies, and leadership capabilities.Â
Education and Experience Requirements
Essential: A minimum of a B.S. / M. S. degree in science or engineering with at least 2-3 years relevant experience executing and or equivalent work experience, developing, and/or administrating GMP quality programs in cGMP cell therapy/ biotech
Knowledge of FDA and EMA regulations and a working knowledge of root cause analysis.
Excellent interpersonal skills and the ability to communicate well, orally and in writing.
Desired: Direct Cell Therapy / Biologic quality experience within Technical Operations.
Key Skills, Abilities, and Competencies
Living our leadership behaviors is a basic expectation for all Takeda employees.Â Takeda expects all employees to embody the following:
Able to perform functions in accordance with cGMP guidelines. Knowledge of regulatory requirements and guidelines for US and Europe.
Ability to create, manage and improve complex Quality systems, integrating with existing systems
Ability to work effectively in a fast-paced environment
Strong written and oral communication skills required
Good interpersonal skills required
Adherence to domestic and international GMP regulations, cGMP's, company policies
Teamwork skills essential
Strong organizational skills
Ability to multi-task in a dynamic environment with changing priorities
Strong work ethic
Ability to meet challenging timelines, in spite of obstacles.
Strong prioritization and delegation skills
Ability to think strategically and tactically, balancing these as workload changes
Self-motivated and driven to independently accomplish department goals and objectives
Positive outlook and motivating, in spite of obstacles
Understands the needs of key collaborators and customers, and interacts effectively intra- and interdepartmentally to achieve alignment and consensus.
Must be capable of defining, implementing, and successfully defending sound QA systems' approaches and principles.Â
Open and honest communication, building authentic relations.Â The individual must be flexible to effectively embrace change.Â
Seeks the input of others before making a decision. Â Demonstrates personal dedication; balances personal needs with Takeda's needs. Â
Demonstrates strategic enterprise thinking to find innovative ways to serve patients, and build trust, reputation and business
Sees opportunities beyond the scope of own role and influences others to adopt new and effective ways of working
Creates the environment that inspires and enables people to move the organization forward
Enables the team to work collaboratively and have challenging discussions.
Focuses on the few priorities that matter most and delivers superior results
Creates clarity, fostering alignment and accountability.
Elevates the capabilities of the organization for now and the future
Invests time in helping others to enhance their skills and perform at a higher level
Complexity and Problem Solving
Employees at this level are involved in a variety of tasks of high level / wide scope and complexity.
This individual will be the primary quality assurance representative on multiple Working Teams and is empowered to make strategic Quality Assurance decisions including troubleshooting issues related to quality concerns, implementing effective solutions and corrective actions.
It is incumbent upon this individual to bring any concerns to direct supervisor or areas of significant cross- functional disagreement to supervisor.
Candidate must be able to perform functions under minimal supervision.Â Receives general instructions on new work; refers to policies and practices for guidance.Â Work is reviewed for technical soundness and accuracy.
Internal and External Contacts
Contacts are primarily with other professionals in the group (Quality) and QA Operations Floor Support, PTS Investigations, Manufacturing, Facilities / Engineering, Regulatory, Quality Control, Validation and other Technical Services departments.
Other Job Requirements
Must be flexible to work late shifts and weekends on an ad-hoc basis, but not common.Â Would be required for Regulatory inspections and/or critical quality systems.
This job posting excludes CO applicants
USA - MA - Lexington - BIO OPS
Internal Number: R0033805
About Biolife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.