Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) .Job DescriptionSupervise a team and is responsible for hiring, leading and developing team members to ensure the department has the appropriate talent and level of performance to meet business objectives. This position is also responsible for assuring donor information is complete, accurate and reviewed to assure donor release requirements adhere to applicable regulatory requirements. They will be responsible for but not limited to, organizing communications with TRP’s, perform donor chart review, donor rejections and testing failures including any ERP system transactions required. They will play a key role in the training of personnel within the department.Responsibilities:
Supervise the activities associated with the donor release process and ensures it conforms with Standard Operating Procedures (SOPs) and all applicable state and federal standards and FDA and AATB regulations.
Communicates with management on a routine basis and escalate issues as needed. Supervises the team by example, builds relationships and collaborates with internal and external customers.
Responsible for managing the activities required to meet the monthly release target.
Responsible for training, developing, motivating, and coaching of the team.
Responsible for ensuring adequate resources/staff to maintain business continuity, assigning work, meeting deadlines, interpreting, and ensuring compliance to organizational policies
Responsible for communicating and/or facilitating personnel actions; including but not limited to hiring, termination, salary and performance reviews, disciplinary action, approving paid time off, and approving overtime.
Provide supervision, coaching and guidance, monitoring of activities, required problem resolutions, and projects. Create and sustain a positive team environment.
Initiate, investigate, review, and/or partner in the identification of discrepancies and issue resolution for Nonconformances, CAPAs, and other quality records as applicable. Initiate IT tickets and Facilities tickets, and Equipment Work Requests (EWRs). Assist with corrective actions in cross-functional teams to mitigate recurrence of similar issues.
Initiate, assess, coordinate implementation plans, and/or drive ECOs for process related to donor release. Provide input and support for other change controls related to the Tissue Services process.
Track and monitor Key Process Indicators (KPIs), implements initiatives to increase departmental and cross-functional awareness and process improvements.
Performs donor review, releases and any other activities as needed.
Ensure Tissue Services documentation is accurate and compliant.
Performs applicable ERP training, transactions, transfer, status changes, and other activities as needed.
Responsible for the initiation and follow-through of the change control processes
Active member in other cross-functional collaborative efforts and attends huddles, team meetings, and project meetings.
Supports 5S methodology and ensures the area is safe and effective working environment
Qualifications
Bachelor’s degree or equivalent preferred
3-5 years’ experience in a GMP environment performing related duties as listed in Key Duties & Responsibilities.
Ability to work a varied schedule with some potential weekend, early morning or late evening hours, if needed.
AATB Certification preferred
SAP Knowledge
Essential Skills:
Advanced computer skills – high knowledge and understanding of Windows-based computer systems such as Microsoft Office Suite.
Experience with Current Good Manufacturing Practices (cGMPs) and working in a regulated industry; familiarity with AATB, FDA, and/or USP regulations guidelines.
Experience with Enterprise Resource Planning (ERP) software, such as Oracle or SAP.
Strong understanding of quality systems.
Basic knowledge of statistical techniques and quality tools
Detail-oriented and self-motivated
Ability to carry out detailed written or oral instructions
Ability to work and communicate (soft skills) with others in a professional and effective manner to build strong, lasting customer relationships and developing a strong team by support and leadership of group work area
Ability to handle a wide variety of tasks under critical time constraints
Strong organizational abilities and problem-solving skills
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:https://www.abbvie.com/join-us/reasonable-accommodations.htmlSalary: $92,500 - $167,000
