Job Description

About AbbVie
AbbVies 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 peoples lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womens 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.

Be part of the dynamic External Quality Assurance (EQA) team responsible for a portfolio of products that include Natural Health Products, Cosmetics, Homeopathic and OTC drugs.

Under general direction, manages a Quality team in the evaluation of products supplied to the Company from the Third Parties and assures that the product is manufactured and controlled in accordance with Company standards, registrations and regulations, both domestically and internationally.

Main Areas of Responsibilities

* Oversight and approval of the activities at the Third Parties for all aspects, including but not limited, to the Quality Management System, product disposition and market release, deviations, CAPAs, stability, annual product review, complaints, vendor approval, validation protocols, method transfers, quality agreements and oversight of outsourced Lead investigations into product non-conformances and deficiencies.
* Assure that all investigations are properly documented, and that corrective actions for prevention of reoccurrence are completed in a timely manner.
* Apply risk management principles in data analysis, decision-making and reporting processes within the areas of responsibility.
* Assure responsible Third Parties are compliant with cGMPs, regulatory and corporate compliance requirements and contractual agreements.
* Support or manage, as appropriate, communications with Regulatory Authorities including both written and verbal, such as for Field Alert reporting to FDA.
* Responsible for ensuring all third party related Agency communication and/or notification activities are consistent with regulatory and company requirements.
* Support, if needed, the Third Party during any regulatory agency inspections for Companys products.
* Negotiate and establish quality agreements and provide quality input for other business agreements for third party manufacturers, suppliers and partners.
* Monitor quality metrics/ key performance indicators for contract sites and contribute to Business Review and Quality Management Review meetings.
* As a member of the EQA team, develop and implement Standard Operating Procedures (SOP's) to assure compliance with regulations, Abbvie corporate standards and contractual agreements, as necessary.
* Strong knowledge of US cosmetic/drug regulations and guidelines. Knowledge in Canadian, European, China and other global regulations also an asset.
* Pharmaceutical processes, principles, practices and their application.
* Responding to inquiries from management, employees and regulatory agencies.
* Researching, interpreting and analyzing reports, compliance requirements, regulations, contracts and data.
* Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures or techniques for resolution
* Administering, and interpreting contractual agreements.
* Excellent interpersonal, oral and written communication skills.
* Demonstrated leadership in managing projects and/or product launches and ability to work independently.
* Excellent negotiation, problem solving and prioritization skills. Strong time management skills, able to manage multiple projects, duties and assignments.
* Ability to work in a team, both in person and remotely and across various departments.
* The ability to influence vertically and horizontally across the organization is essential.
* Must be able to travel, including outside of USA. Travel is estimated to be 10%-15%.

Qualifications
Education and Experience

* Bachelors Degree required, science/pharmaceutical related degree preferred.
* Minimum of two (2) years prior pharma/cosmetic manufacturing management or seven (7) years in the pharmaceutical/cosmetic industry, preferably with engagement of outsourced service providers such as manufacturers and packagers.
* QC laboratory, drug/cosmetic manufacturing, validation or R&D; experience
* Extensive knowledge of the Regulations/GMPs and experience with regulatory authorities including at a minimum the FDA. Knowledge of other global regulatory authorities is an asset.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.