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Senior Quality Assurance Specialist - Compliance

Company: Takeda Pharmaceuticals International GmbH
Location: Cambridge
Posted on: September 17, 2020

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the Coronavirus (COVID-19), we’re leveraging our digital capabilities to ensure we can continue to recruit top talent at Takeda. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our colleagues will explain how these tools will be used during the recruitment process. Thank you.

*Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers. See below or here for more info.

Senior Quality Assurance Specialist - Compliance Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

Success What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

Senior Quality Assurance Specialist - Compliance Job ID SR0052753 Date posted 09/11/2020 Location 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.

Review and approval of Quality Systems which include deviations and CAPA as well as supporting disposition as appropriate.

Collaborates with multiple departments to ensure appropriate RCA and CAPAs have been identified.

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-wide goals.

Responsible for adhering to GMP regulations, cGMP’s, company policies, and leadership capabilities.

Education and Experience Requirements

A minimum of a B.S. degree in science or engineering with at least 4+ 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.

Direct Biologic Pharmaceuticals experience within Technical Operations.

Key Skills, Abilities, and Competencies

Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda 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.

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.

Flexible

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.

Works effectively in situations that are outside 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 Takeda’s needs.

Demonstrates dedication to Takeda by going above and beyond the expected individual responsibilities.

Leadership Behaviors

Be Positive.

Be Accountable.

Be Results Oriented.

Be An Excellent Manager of Self and Others.

Complexity and Problem Solving

Employees at this level are 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 minimal 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 and other Technical Services departments.

.

Other Job Requirements

Must be flexible to work late shifts and weekends on an 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, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda 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.

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, 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/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, 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.

Job ID SR0052753

Check out where you could be

working if you apply.

Job Seekers: Protect yourself against identity theft Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers.

Copyright 1995-2019 Takeda Pharmaceutical Company Limited. All rights reserved.

Keywords: Takeda Pharmaceuticals International GmbH, Cambridge , Senior Quality Assurance Specialist - Compliance, Other , Cambridge, Massachusetts

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