PDL BioPharma is a leader in the discovery, development, and marketing of innovative therapies for acute-care environments.

Our current product pipeline includes six breakthrough investigational compounds for the treatment of cardiovascular disorders, cancer, and other serious illnesses.

Pioneering science, strong commercial products, and a rich development pipeline define PDL BioPharma.

And our success is based on one key factor—our people.

At PDL BioPharma, every employee directly contributes to the development and delivery of innovative therapies that help make real a difference in people's lives.

We foster a goal-oriented and entrepreneurial culture where teamwork, commitment, and initiative are valued and rewarded.

Products.

Pipeline.

People.

PDL BioPharma invites you to be part of the future of biotechnology.

We are proud to be an equal opportunity employer.

Job Description The candidate is responsible for managing the Quality Assurance audit program and overseeing Annual Product Reviews at PDL's Minnesota facility, to ensure compliance with applicable federal and international regulations.

This position reports to Quality Assurance management.

Responsibilities: · Coordinates FDA internal and external audit programs to ensure compliance with applicable federal and international regulations.

Program includes: SOPs, templates, managing and tracking of audit schedule, tracking audit actions to closure, verifying effectiveness of corrective and preventive actions taken, and managing trending reports.

· Develops and administrates an ongoing training program for PDL internal and external auditors.

· Interacts with other departments and PDL management to assure that the audit program meets needs and adds value.

Makes continuous improvements based on input.

· Interacts with IS to implement and improve electronic systems for tracking and reporting.

· Coordinates and manages schedule for Annual Product Reviews (APRs).

· Coordinate with contract manufacturers to assure that APRs are delivered on time to expectations.

· Implements continuous improvements to the APR process that assure that trends and improvement opportunities identified during the review are effectively communicated to PDL management.

· Communicates effectively with personnel from other departments and PDL management to assure that systemic issues identified during audits are evaluated, understood and addressed at the root cause level.

· Prepares and provides support for FDA and other regulatory agency inspections to assure that the PDL personnel are prepared, records are readily available, an efficient system is in place for delivery and tracking of records and personnel presented to the agency.

· Maintains up-to-date knowledge of applicable federal and international regulations, validation principals and requirements, industry standards and guidelines, and internal policies and procedures.

Required Skills · BS degree in a scientific discipline and 2-5 years experience (or an Associate's degree with 6+ years experience) in the pharmaceutical or biotechnology industry, preferably in the Quality Assurance, Manufacturing and/or Analytical Laboratory area(s).

· Thorough understanding of FDA GMP regulatory requirements (cGMPs, GLPs and GCPs) and other regulatory guidances.

· Experience in preparing for and participating in regulatory agency inspections.

· Familiarity with internal and external auditing.

· Detail oriented with the ability to coordinate activities among several groups with a sense of urgency.

· Ability to effectively plan, schedule and perform assigned job duties.

· Ability to work on complex problems where analysis of the situation or data requires a review of identifiable factors to determine the root cause.

· Strong oral and written communication skills.

· Proficiency in Microsoft Office software (Outlook, Word and Excel).

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