QA Manager, Technical Services

Company Description

About AbbVie

AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of site leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QA Site Director.

Responsibilities

• Manages the Quality Control (QC) laboratory including direct reports and budgetary responsibilities
• Member of the Laboratory Center of Excellence (COE)
• Serves as the standalone laboratory systems and site Maximo administrator
• Reviews and approves raw materials and commodities including ERP approval
• Exception Report (ER) investigation, writing, review, and approval including ensuring effective CAPAs
• Qualification and validation protocol writing, review, and approval
• Actively participates in Periodic Validation Reviews, Annual Product Reviews, internal audits, and process data reviews
• Provides front room and laboratory SME support during regulatory agency and internal inspections
• Manages change related to compendia, supplier/service provider notifications, material specifications, analytical test methods, test method validation, SOPs, batch records, and site service requests
• Leads the implementation of Quality-related projects including metrics

Significant Work Activities: 

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Continuous walking for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Frequent to continuous computer usage (greater or equal to 50% of the workday) is required

Qualifications

• Bachelor’s degree with 10 years of pharmaceutical Quality experience (preferably in QC).
• Previous experience leading teams in highly desired. 
• Strong background in Quality/ QC within the Pharmaceutical and/ or Biotechnology industry.
• Excellent oral and written communication skills required with the capability of clearly presenting and justifying quality requirements.
• Key leadership competencies include cultural awareness, relationship building, ability to influence at all levels of the organization, teamwork building, sound judgment and the ability to make difficult decisions, often at short notice.

Additional Information

Applicable 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 thisposting 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 long-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 anduntil 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 and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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.html