Shire Supervisor-QA Operations 1st Shift - Lex in Lexington, Massachusetts

PRIMARY ROLE

The Manager leads a team of Quality Assurance (QA) Specialists that are responsible for QA oversight of QC Analytical and Microbiology laboratories at the Massachusetts Biologics Operations (MBO) Lexington Site. The QA Manager will also provide support to GMP manufacturing facilities in partnership with management colleagues within the QA Operations Team at the MBO manufacturing plants. The focus of this role is Quality oversight of cGMPs and GLPs as they relate to QC laboratories with direct management of senior level QA Specialists.

Responsibilities include, but are not limited to: Management of direct reports that support routine laboratory activities, establishing a routine QA On-the-QC-laboratory floor presence, work with QC colleagues and management to enhance Data Integrity and GDP standards across the Quality organization, close partnership with Quality oversight groups responsible for method and instrument qualification activities. Monitors policies, processes, procedures and controls ensuring that Quality Management System performance meets high level standards.

The role demonstrates high level of involvement in continuous improvement efforts paired with quality and compliance standards and practices to ensure compliant manufacture and Quality Control processes. Examines programs to create efficiencies in practices and optimal utilization of staff with a focus on execution of core job functions across QA and QC groups. Assures cGMP's and company procedures are followed and, if needed, procedures/policies are revised. Performance of the QA Manager and staff play a significant role in the overall quality and safety of products manufactured and tested at the Mass Bio Operations.

RESPONSIBILITIES

Direct responsibilities include management of staff with oversight of:

  • Staffing the site QA group and leading a group of QA professionals, assuring effectiveness and efficiency of staff; assessing performance of direct subordinates through coaching, mentoring and performance management

  • Ensuring a robust Data Integrity program within the QC laboratories including, but not limited to partnership with Laboratory Management and Quality Regulatory Compliance on routine audit trail reviews, data integrity audits and educational efforts.

  • Oversight of QA Specialists responsible for daily support of laboratory operations including, but not limited to, QA Contact on deviations/change controls and CAPAs along with Quality oversight of routine daily laboratory operations.

  • Partnership with colleagues within Quality Assurance on site Quality and Improvement initiatives.

  • Lead and facilitate routine walk-throughs of the Quality Control laboratories.

  • Cross functional collaboration with applicable Quality oversight groups of instrument control and qualification activities and Stability program oversight.

  • Support internal and external audits and inspections through a multitude of efforts including routine GMP walk-throughs, baseline quality and compliance education building across the organization and direct inspection support.

  • Responsibility for adhering to domestic and international GMP regulations, cGMP's, GLP’s, company policies, leadership capabilities, performance management and department budget.

  • Assuring appropriate GMP and QA systems training of QA personnel.

  • Support of management colleagues responsible for Quality oversight of GMP Manufacturing areas.

  • Leading and/or representing Quality or QA on multidisciplinary teams, as required.

ADDITIONAL JOB DETAILS

Employee at this level is involved in a variety of tasks of moderate to high level scope and complexity. The individual will be responsible for providing guidance on prioritization and resource allocation within QA Operations and communicating priorities to staff for execution. Responsible for monitoring progress towards timelines, goals and objectives. Responsible for defining and implementing site-specific QA approaches based on existing guidance and quality standards, sound principles, international industry/regulatory standards, and robust scientific basis.

Responsible for proactively implementing preventive actions to fill compliance gaps and troubleshooting issues related to quality concerns, implementing effective solutions and corrective actions.

INTERNAL AND EXTERNAL CONTACTS

In addition to routine interaction within QA line management, key collaborations for position involve peers (Manager and Sr Manager levels or appropriate representative) from the following departments:

  • Quality Control

  • External (Global) QA groups

  • Quality Control Stability

  • Manufacturing

  • Facilities & Engineering

  • Materials Management

  • External: Regulatory Agency personnel

EXPERIENCE AND EDUCATION REQUIREMENTS

  • Minimum 10 years’ experience working in a Quality Role in the pharmaceutical/biotechnology industry. Prior supervisory experience is a strong desire for this position.

  • Minimum Bachelor’s degree in a technical field including, but not limited to: pharmacy, chemistry, biology or related discipline. Education in a field suitable for a Quality oversight of the Quality Control laboratory is desired.”

  • Thorough understanding of quality systems, cGMPs, GDPs and GLPs

  • Leadership and strategic thinking in the area of electronic systems and data integrity (21 CFR).

  • Experience with Biological manufacturing and test laboratories

  • Experience leading, training and/or implementing root cause analysis and effective investigation practices

  • Demonstrated ability and accomplishments implementing corrective actions and process improvements for more complex and technical challenges (or leading individuals/teams with these demonstrated accomplishments).

  • High level of professional competence (example: Certified Quality Auditor)

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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.

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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.