Shire Head of Massachusetts Site Quality in Cambridge, Massachusetts
This role will serve as the lead for all Quality activities at the Massachusetts Biologics Site with plants in both Lexington and Cambridge, MA. The overall responsibility of this role is to design and execute the strategy for compliance to Good Manufacturing and Good Distribution Practices for all MA operations (B200, B300, B400, and Alewife) for in accordance to Shire’s global standards.
Responsibilities include QA oversight and compliance of: quality systems (change control, CAPA and deviations); audit support; plant QA operations; internal product technology transfer; and facility compliance. Responsible for bulk drug substance manufacturing/ testing oversight and final lot disposition for commercial and clinical (DS specific) use. Responsible for review and approval of site validation activities. Responsible for Quality Control site testing including raw materials, environmental monitoring, and microbiology and oversight of related investigations. Overall responsibility for cross-plant quality alignment. Responsible to act as a primary interface in conjunction with the Head of Quality - Biologics between MA Site Quality and the supporting Central Quality support functions (ex. Central Product Testing, Clinical QA, Center QA Validation, and others) to ensure site support needs are met as well as adherence to Shire’s global standards.
Sets strategy to enhance and maintain Biological Quality globally including oversight of:
Strategic oversight and leadership to meet functional and site goals and objectives
Responsibility for adhering to domestic and international GMP regulations, cGMP’s, , company policies, leadership behaviors, and performance and budget management
Lead and coach direct team and drive a high performance organizational culture that accommodates rapid growth and highly dynamic expectations
Responsible for timely updates of site achievements and challenges to management with a focus on quality compliance, operations performance, staff performance and productivity, staff development, continuous improvements, key projects support and identification and resolving obstacles to maintain a highly effective and productive functional group.
Interact regularly with customers to meet the needs and communicate activities and issues to line Management on a regular and timely manner
Execution of product disposition (drug substance)
Ability to lead complex material review boards to determine the ultimate outcome of complex deviations/dispositions which are based on data, science, and compliance
Accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations)
Responsible for Quality Control related testing and sampling for site (Microbiology, Environmental Monitoring, Raw Materials) as well as quality assurance review of site validation activities
Development and refinement of groups’ quality systems and procedures
Management of cross-plant quality issues and implementation of harmonized cross-plant quality philosophy; ensures consistency in quality operations across plants.
Provide QA support for electronic system integration (i.e. SAP, TW, etc) into MA site?QA support for electronic systems:, LIMS, Trackwise, SAP etc.
Champion MA plant metrics to ensure targets are achieved, met and countermeasures in place when applicable,
Assuring appropriate GMP and QA systems training of QA personnel and customers
Responsible for site specific QMR management and gathering of APQR data
Preparing for/ supporting/ leading regulatory inspections and third party audits
Providing information to regulatory submissions as necessary
Creation and management of the Site Master Files & management of site (plant) licensuresLeading and/or representing Quality on multidisciplinary teams
Responsible for timely hiring, training and development of qualified staff to ensure effective execution of roles and responsibilities, GMP compliance, and attainment of operational and development goals.
Maintaining daily staffing requirements to meet business needs.
Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs.
Promote and exhibit Shire Values
Executing company policies
Ensuring self inspections are performed
Escalating and ensuring risk champions are established
Ensures new/revised quality system requirements are deployed to the Site
Ensures execution leads for Quality-owned business processes are established who work with the business process owner to continually improve processes.
Education and Experience Requirements:
The ideal candidate will have the following education and experience
Degree in technical discipline such as biochemistry, chemistry, engineering
Advanced degree in complimentary field of study (preferred?)
At least 12 years of experience in the biotechnology and/or pharmaceutical industry, preferably both
Experience leading teams
Proven people manager and leader capable of developing people and teams with at least 8 years of management experience.
Track record of effective Quality leadership for internal production facilities, testing, sampling, and product disposition
Experience in providing Quality oversight for engineering and validation projects supporting internal operations and tech transfer activities
Experience leading, training and/or implementing root cause analysis and effective investigation practices
Strong operations background to ensure value added and effective quality operations. Experience driving out inefficiencies and improving turnaround times
Understands regulations pertaining to licensing, import/export, , and transportation requirements. (GDP activities…per comments made above)
Experience applying appropriate regulations in emerging markets and/or where requirements are ill defined or ambiguous
Working in a multinational organization effectively navigating differing regional expectations
Equal Employment Opportunity
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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.