Product Quality Lead (21600)

Company: Alexion Pharmaceuticals
Location: New Haven
Posted on: September 12, 2020

Job Description:

Career Opportunities: Product Quality Lead (21600) Req Id  21600  - Posted  08/13/2020  -  United States  -  New Haven, CT  -  Quality

This position can be located in an Alexion office in the following cities: Boston, MA; New Haven, CT, San Francisco, CA or Blue Bell, PA

Position Summary

The Product Quality Lead (PQL) is responsible to provide product quality stewardship of our products from introduction throughout the lifecycle. As the product quality expert, the PQL will build the strategy to proactively minimize product quality risks through early detection and mitigation during product development, technology transfer, commercial operations, and product discontinuation. The PQL is the Quality liaison between Regulatory Affairs and Operations to ensure regulatory compliance of manufacturing and testing processes. The role enables efficient communication and decision making related to the quality of our products.

The position reports into the Sr. Director, Product Quality Lifecycle Management

Responsibilities:

Proactively manage product quality risks ensuring they are proactively mitigated, actioned, and escalated to senior management

Assess data trends and provide product quality insights regarding product stability, process monitoring, and other key quality system outputs

Act as Quality advocate and single point of contact for global program strategy teams to ensure consistent quality approach to GMP manufacturing, testing, release, and regulatory filings.

Act as Quality expert for product quality history through lifecycle

Maintains Product Quality Monographs and Supply Chain Maps in compliance with investigational product and commercial marketing application

Authors Global Annual Product Quality Review, coordinating with leads of contributing chapters, and manages commitments to closure.

Provides lead quality review of CMC sections of Regulatory submissions and response to queries. Facilitates management and closure of post marketing regulatory commitments.

Lead Stability Review Boards to enable primary Quality oversight of the stability program including ensuring annual commitments are met.

Primary Quality oversight of reference standard program with a focus on ensuring supply

Supports process lifecycle and analytical lifecycle management initiatives

Partner with other Quality colleagues on significant product quality impact assessments, particularly for notifications to management, BPDRs, recalls, etc.

Facilitates global changes with respect to the product

Provides support where needed in the creation of Quality Target Product Profiles and product characterization and comparability assessments in line with regulatory expectations

Supports Health Authority inspections and compliance

Education and key competencies:

B.Sc. degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry.

Preferable 10 years’ cGMP experience within quality in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment, ideally pre-clinical phases through commercial

Understanding of pharmaceutical bulk and drug product development and manufacturing

Experience with review of market applications, IND, supplements or similar regulatory documentation

Demonstrated ability in decision making, problem solving and project management.

Collaborate, negotiate, influence and lead in a matrix organization

Excellent communication and interpersonal skills

Proven record in demonstrating agility

Flexibility to travel in support of the role

Knowledge of quality systems with a strong business and technical acumen would be an advantage

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Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) as well as the first and only approved complement inhibitor to treat atypical hemolytic uremic syndrome (aHUS), anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing several mid-to-late-stage therapies, including a second complement inhibitor, a copper-binding agent for Wilson disease and an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases as well as several early-stage therapies, including one for light chain (AL) amyloidosis and a second anti-FcRn therapy. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes' list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.

As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.

Keywords: Alexion Pharmaceuticals, New Haven , Product Quality Lead (21600), Other , New Haven, Connecticut