Director, Quality Assurance
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Director of Quality Assurance
The Quality Assurance Director is a member of the site Senior Leadership Team (SLT). The responsibility of this position is to ensure the Quality Management System is implemented and maintained in conformance with regulatory requirements. The QA Director plans and executes activities related to all aspects of quality assurance and quality control with minimal direction. This position also ensures the conformity of the products to the specifications and promotes and environment of continuous improvement and a patient-focused quality mindset within the organization.
Specific responsibilities include management and oversight of Quality Operations, Quality Control, Supplier Quality Management, Document Control, Training, Internal Audits and CAPA subsystems.
Essential Duties and Responsibilities include the following (other duties may be assigned.):
Provide Quality leadership, strategy and direction for the body contouring locations in Dublin, Pleasanton, and Livermore, CA locations. Establish “best in class” global quality practices to support the business. Monitor and evaluate product manufacturing plants to ensure compliance to regulatory standards and practices, continuous improvement, escalation of issues and ensuring corrective and preventive actions are implemented.
- Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.
- Support successful product realization and provide strategic direction for the functional area regarding compliance and quality. Proactively identify, communicate and prioritize risks and work with business partners to mitigate identified risks.
- Responsible for recruiting, managing and leading Quality departmental staff.
- Lead cross-functional implementation of new standards and regulations.
- Establish and continually improve quality systems.
- Establish and maintain a Document Control & Employee Training System capable of meeting regulatory, quality and company requirements.
- Manage ZELTIQ’s Nonconformance and CAPA process.
- Manage ZELTIQ’s Internal Audit program.
- Promote awareness of regulatory compliance and customer requirements throughout the organization and collaborate with other departments to ensure compliance quality requirement.
- Establish and track Quality metrics.
- Act as Management Representative
- Jointly, with Regulatory Affairs, act as the Person Responsible for Regulatory Compliance who has responsibility and authority for ensuring:
- conformity of the device is checked in accordance with the QMS before release;
- regulatory documentation is prepared and maintained;
- post-market surveillance obligations are met;
- timely responses to market surveillance requests from the competent authorities are made;
- requirements for submission of vigilance reports are complied with, and
- compliance of devices used for clinical investigation is documented.
(The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation.)
- Present periodic reviews of the suitability and effectiveness of the Quality Management System to Senior Management in the form of Management Review meetings.
- Manage direct and indirect reports, including interviewing, selection, performance feedback, discipline, pay decisions and hiring/firing decisions.
- Maintains compliance to internal procedures, FDA, ISO and other applicable regulations.
- Perform other related duties as assigned.
- Bachelor’s degree required in a scientific discipline
- Minimum 10 years of experience in medical device manufacturing
- Minimum of eight (8) years of experience in people leadership.
- Experience in the CE Product Marking process and global regulatory submission process.
- In-depth knowledge and experience in the medical devices in major markets, globally.
- In depth knowledge and experience with quality system and regulatory processes including risk management, complaint handling, regulatory submissions, CAPA, NCR supplier management, product development, design control and global registrations.
- The requisite expertise of the PRRC shall be demonstrated by either of the following qualifications:
- a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
- four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
- Operates with an enterprise perspective.
- Inspires and motivates others toward a shared purpose.
- Influences colleagues to achieve cross-functional alignment.
- Manages inclusively and equitably across all.
- Deals comfortably with risk and ambiguity, changing course when needed.
- Knows the business and the cross-functional contributions needed to deliver results.
- Makes timely, high-quality decisions.
- Acts consistently with our ethics, obligations and the law.
- Sets clear strategies and implementation plans.
- Gives full accountability when delegating; accepts full accountability when delegated to by others.
- Delivers business results.
- Persistent and resilient—finds the way to move good ideas forward.
- Acts respectfully yet courageously; says what needs to be said.
- Manages conflict and difficult conversations in a constructive, transparent way.
- Uses mistakes, failure and reflection as vehicles for learning and improvement.
- Communicates openly and honestly with all colleagues.
- Ability to work in a multinational and multicultural environment.
Language and Verbal Skills:
Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Analytical and Reading Skills:
Ability to read, understand and follow company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear; up to 8 hours per day. The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.
Most work is performed in an office-like and manufacturing setting. The noise level in the environment is usually low to moderate.
ZELTIQ is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.