Shire Associate Director Quality Control in Milford, Massachusetts

Supervise, plan, organize, direct and evaluate all activities of the Quality Laboratory to ensure the safety and reliability of Baxter products, and to comply with quality and regulatory requirements. Making critical decisions to release raw materials, in-process testing and final release of finished products in a timely manner. Identify potential risks associated with laboratory operations and lead teams to resolve lab issues. Serve as a contact person for the Quality Laboratory, and manage all Quality and Regulatory Inspections. Work closely with manufacturing and product development teams to ensure product safety.

Essential Duties and Responsibilities:

  • Provide Quality Laboratory long-term objectives, general policies and management guidance based on business directions and goals.

  • Interpret applicable quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules, and guidelines), develop policies to implement these requirements for the laboratory operation.

  • Ensure compliance with testing SOPs and specifications. Monitor the testing techniques and accuracy of all records and documentation that is done in the lab.

  • Work closely with manufacturing and product development teams and participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.

  • Manage CPA's and operating budget for the lab.

  • Assure compliance with company procedures. Prepare the department ready for an audit by both internal and external authorities. Serve as the Quality Management for the lab. and interface with investigators during these inspections.

  • Assure a safe and non-discriminatory working environment for employees.

  • Ensure employees are properly trained and audited. Make appropriate staffing recommendations. Evaluate performance via performance appraisals and insure employees have development plans.

  • Work with teams of business units and meet operational goals.

Qualifications:

Must know quality laboratory operations and government regulations pertaining to pharmceutical and medical device manufacturing labs. very well. Must have the ability of managing complex projects and resolving complex lab. Issues. Must possess excellent supervisory and interpersonal skills, and be able to communicate with all level personnel and regulatory authorities. Should have advanced knowledge in Statistical Analysis, QSR, cGMP, CFR, USP and GDP. Strong leadership, project and people management skills, and ability to make critical decisions. Strong understanding of business and/or industry.

Education and/or Experience:

Bachelors Degree in Chemistry, or biological science with 9-13 years experience, or Masters Degree in Chemistry, or biological science with 7-11 years experience, PhD in relevant scientific field with 4-8 years experience.

Minimum 2-3 years of management experience.

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Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.