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Shire Sr QA Specialist - Compliance in Cambridge, Massachusetts
Primary Duties :
This individual is responsible for providing senior level support for issues of moderate complexity at a minimum. Routine management & coordination of GMP compliance systems and policies for cGMP compliant facilities for bulk drug substance disposition. Monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained. Examines programs to create efficiencies in practices and optimal utilization of staff. Review of production records for compliance. Assures cGMP’s and company procedures are followed and, if needed, procedures/policies are revised. Accountable for meeting functional area goals and objectives as they relate to departmental and company-wise goals. Responsible for adhering to GMP regulations, cGMP’s, company policies, and leadership capabilities.
Support of customer group quality systems
Develop and aid in development of solutions for moderate to complex problems
Work on moderate to complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
Exercise judgment in selecting methods, techniques and evaluation criteria for obtaining results
Network with key contacts outside own area of expertise
Contribute to the development of new concepts, techniques, and standards
Work independently without appreciable direction
Exercise latitude in determining objectives and approaches to assignments
Serve as special external spokesperson for the organization on major matters pertaining to its policies, plans, and objectives
Ensuring that practices are consistent with quality and regulatory standards
Providing support during regulatory agency site inspections
Support an environment of teamwork and collaboration
Project and improvement initiative participation
Education and Experience Requirements:
Essential: A minimum of a B.S. degree in science or engineering with at least 3-5 years relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments.
Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis.
Excellent interpersonal skills and the ability to communicate well orally and in writing.
Desired: Direct Biologic Pharmaceuticals experience within Technical Operations
Key Skills, Abilities, and Competencies:
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
Able to perform functions in accordance with cGMP guidelines. Knowledge of regulatory requirements and guidelines for US and Europe.
Ability to create, manage and improve complex Quality systems, integrating with existing systems
Ability to work effectively in a fast-paced environment
Strong written and oral communication skills required
Good interpersonal skills required
Adherence to domestic and international GMP regulations, cGMP’s, company policies and DNA leadership capabilities.
Teamwork skills essential
Strong organizational skills
Ability to multi-task in a dynamic environment with changing priorities
Strong work ethic
Ability to meet challenging timelines, in spite of obstacles.
Strong prioritization and delegation skills
Ability to think strategically and tactically, balancing these as workload changes
Self-motivated and driven to independently accomplish department goals and objectives
Positive outlook and motivating, in spite of obstacles
Understands the needs of key collaborators and customers, and interacts effectively intra- and interdepartmentally to achieve alignment and consensus.
Must be capable of defining, implementing, and successfully defending sound QA systems’ approaches and principles.
Demonstrate unwavering ethics and respect for all customers. Practice open and honest communication, building authentic relations. The individual must be flexible to effectively embrace change. When faced with challenging circumstances, finds creative ways to ensure achievement of the desired outcome. Plans, organizes and communicates with others who may have concurrent work streams. Proactively improves customer service. Demonstrate genuine respect for others. Seeks greater understanding of self and others: seeks feedback about one’s own behavior Demonstrates leadership qualities. Works effectively in situations that are outside one’s usual activities and responsibilities. Fosters employee ownership and development by allowing others to make independent decisions and judgments.
Seeks the input of others before making a decision. Demonstrates personal dedication; balances personal needs with Shire’s needs. Illustrates dedication to Shire by going above and beyond expected individual responsibilities.
Be Results Oriented
Be An Excellent Manager of Self and Others
Complexity and Problem Solving:
Employee at this level is involved in a variety of tasks of high level / wide scope and complexity.
This individual will be the primary quality assurance representative on multiple Working Teams and is empowered to make strategic Quality Assurance decisions including troubleshooting issues related to quality concerns, implementing effective solutions and corrective actions.
It is incumbent upon this individual to bring any concerns to direct supervisor or areas of significant cross- functional disagreement to supervisor.
Candidate must be able to perform functions under least supervision. Receives general instructions on new work; refers to policies and practices for guidance. Work is reviewed for technical soundness and accuracy.
Internal and External Contacts:
Contacts are primarily with other professionals in the group (Quality) and QA Operations Floor Support, PTS Investigations, Manufacturing, Facilities / Engineering, Regulatory, Quality Control, Validation, MS&T.
Other Job Requirements:
Must be flexible to work late shifts and weekends on ad-hoc basis, but not common. Would be required for Regulatory inspections and/or critical quality systems.
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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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.