QA Director

BioSpace; Worcester (MA); On-site; USD 156,000 - 297,000; Full time

Job summary

BioSpace is seeking a QA Director to lead quality assurance efforts, ensure compliance with industry regulations, and develop effective quality control strategies. This role demands extensive experience in Quality/Regulatory areas within pharma, making it essential for candidate development and collaboration with manufacturing teams.

Benefits

Paid time off

Medical, dental, and vision insurance

401(k) plan

Short-term and long-term incentive programs

Qualifications

• Minimum 15 years relevant experience in Quality/Regulatory in pharma or medical device.
• Demonstrated knowledge in Quality Systems and Operations practices.
• Ability to gown and enter cleanroom processing environments.

Responsibilities

• Establish a Quality Control Strategy and ensure quality requirements are met.
• Monitor compliance with FDA 21CFR regulations and standards.
• Assess team performance and implement improvement initiatives.

Skills

Quality Systems

Quality Operations practices

Leadership

Strategic planning

Risk analysis tools

Education

Bachelor's degree in Business, Biology, Engineering, or related scientific field

Job description

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Company Description

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 immunology, oncology, neuroscience, and eye care. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Company Description

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 immunology, oncology, neuroscience, and eye care. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

Purpose

The Director of Quality Control , Quality Assurance, Product Release, or Tissue Services is a key member of the quality leadership team and reports directly to the Site Head of Quality. This role is responsible for providing strategic leadership, appropriate staffing, and sustaining a quality culture, in line with the organizations global strategy and the site's goals and objectives.The incumbent is responsible for strategic direction of one or more of the following functions/teams: Supplier Controls/Incoming Material Inspection, Incoming Tissue Inspection, Final Product Packaging Inspection, Product Release, Donor Eligibility and Release, Product Change Control, Facility/Utility/Equipment Qualification.

Responsibilities

• Establish a Quality Control Strategy for all applicable products and implement appropriate processes and staffing for strategy achievement, which includes the following areas: Incoming material inspection and release, lot review and release, final packaging inspection, Donor review process
• Carry out duties as a leader within the quality organization to ensure quality requirements are met. Act as delegate; Management with Executive Responsibility, Management Representative, or Person(s) Responsible for Regulatory Compliance: The conformity of the product/device is checked in accordance with the quality management system before release and compliance of product/device used for clinical investigation is documented.
• Monitor and implement processes to ensure compliance with Regulations and guidelines including, but not limited to, FDA 21CFR1271, 210, 211, 806, and 820, ISO9001 and 13485, Canadian regulations, Tissue Banking Standards, and Global and State regulations, Benchmark and leverage best practices in the industry and with key corporate partners.
• Assess Team performance using metrics and implement improvement initiatives where gaps or trends are identified. Act as a leader and role model to all Quality employees
• Partner with manufacturing to achieve product supply goals while ensuring compliance with quality requirements and applicable regulations. Participate in market demand forecasting and align resources to meet demand
• Ensures project deadlines and performance standards are established and met
• Ensures the creation of goals and objectives in alignment with the overall strategy
  
  
  

Qualifications

• Bachelor's degree required in Business, Biology, Engineering, or related scientific field from an accredited college or university
• Minimum 15 years of relevant experience in Quality/Regulatory in pharma, biologics, medical device, or relevant regulated industry.Additional experience outside Quality/Regulatory functions desired.
• Demonstrated knowledge in Quality Systems, Quality Operations practices, and procedures.
• Demonstrated people management skills including leadership, strategic planning, delegation, and follow up along with recruiting, developing, and retaining key talent
• Knowledge of risk analysis tools and statistical methodology
• Ability to gown and enter cleanroom processing environments and work within an office setting
  
  
  

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.Salary: $156,000 - $296,500
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible to participate in our short-term incentiveprograms.
• This job is eligible to participate in our long-term incentiveprograms
  
  
  

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable 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, visithttps://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

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Internet News

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