Clinical Vendor Quality Assurance & Compliance Lead

Employment Type

: Full-Time


: Scientific Research

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**Job Summary:**

Under the direction of the Head of Internal & Supplier Audits, this position is responsible for coordinating the execution of the overall Internal Suppler Audit strategy and R&D QA & Compliance (QA&C) Operational objectives.

Primary responsibilities of this position are to:

+ Provide professional expertise and strong leadership in applicable guidance and regulations, proactively identifying potential areas of non-compliance and risk for assigned areas.

+ Execute Internal Supplier Audit strategy at the direction of the Head of Internal & Supplier Audits

+ Serve as a QA & Compliance Liaison for Preferred Providers Governance Councils or internal committees, as assigned

+ Provide Compliance & Management Support for identified issues arising with supported R&D Business areas, and for other QA & Compliance project initiatives

+ Provide support for QA & Compliance Regulatory Agency Inspections


30-50 %

**Audit Coordination**

+ Liaise and network with internal and external business partners to implement ISA strategy

+ Lead the planning, execution and close out of assigned ISA audits

+ Lead ISA driven CAPAs, effectiveness checks, and issue escalation, as assigned

+ Designated auditor/co-auditor for assigned ISA audits

+ Lead ISA facilitated meetings.

+ Participate in QA&C project initiatives (System Development and COE driven)


**QA&C Liaison for Preferred Provider(s)**

+ Liaise and network with internal and external business partners to provide guidance and support pertaining to compliance/quality oversight initiatives

+ Prepare and lead or support governance council meetings

+ Facilitate issue escalation and oversight of remediation as appropriate

+ Manage preferred provider partnership as assigned


**Internal Supplier & Audits and QA & Compliance Suppor** t

+ Liaise and network with internal and external business partners to implement ISA and QA&C initiatives

+ Lead and/or support the planning, execution and close out of assigned ISA and QA&C initiatives

+ Provide compliance guidance and support for R&D as appropriate

+ Provide support to management as requested


**Regulatory Agency Support**

+ Support, as needed, the preparation, conduct follow-up/responding, and lessons learned to GXP inspections

**E** **duca** **ti** **on and** **E** **xpe** **r** **i** **e** **nce** **R** **equ** **i** **r** **e** **men** **t** **s**

+ Bachelor's degree in a life science or equivalent experience; Graduate degree in a scientific discipline or program management a plus

+ Minimum of 8 years' of pharmaceutical experience, including international experience

+ Ideal candidate will have broad experience in product development, regulatory compliance, supplier management, GxP auditing and at least 3 years of direct or matrix management experience

**K** **e** **y** **S** **k** **ill** **s,** **A** **b** **iliti** **e** **s** **, a** **n** **d** **C** **ompe** **t** **en** **c** **i** **es**

+ Extensive knowledge and/or awareness of local and international regulations.

+ Maintains awareness of newly published regulations.

+ Strong understanding of the: drug development processes, clinical development operations, vendor outsourcing and procurement processes, regulatory affairs, GXP and internal process auditing

+ Collaborative team player who has the ability to think and act quickly and identify creative solutions to complex problems

+ Robust technical writing skills. Ability to write briefing documents, quality positions, audit reports and SOPs.

+ Strong attention to detail with the ability to articulate quality related risks and potential impact.

+ Leadership skills, and ability to inspire colleagues

+ Ability to take a big-picture approach to decision-making while taking account of the broad interests of Takeda.

+ Strong project management and decision-making skills

+ A self-starter, who motivates, has tact and diplomacy and is able to define and prioritize tasks within a project

+ Excellent communication and interpersonal skills.

+ Demonstrates ability to manage global staff/activities

+ Ability to foster and balance a culture of compliance within a culture of innovation

+ Strategic thinking

+ Ability to influence without authority, in a matrix environment

+ Proficient knowledge of MS Word, Excel, PowerPoint & Outlook; working knowledge of Access, Trackwise a plus

**C** **omp** **l** **ex** **i** **t** **y and** **P** **rob** **l** **e** **m** **S** **o** **l** **v** **i** **ng**

+ Exerts influence in the development of overall objectives and long-range goals of the organization.

+ Acts as an advisor to meet schedules or resolve technical or operational problems

+ Directly participates in establishing and administering centralized functional projects

+ Works on complex problems requiring analysis of situations or data and in-depth analysis of factors

+ Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

**I** **n** **t** **ern** **a** **l and** **E** **x** **t** **e** **rnal** **C** **on** **t** **ac** **t** **s**

+ Interacts across R&D QA & Compliance and R&D Business Partners

**Ot** **h** **e** **r Job** **R** **equ** **i** **r** **e** **men** **ts**

+ Domestic and international travel may be required per business need.

+ Must have a global mindset.

**_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._

Equal Employment Opportunity

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 -

EEO is the Law - Supplement -

Pay Transparency Policy -

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-###-#### and let us know the nature of your request and your contact information.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people's lives - including your own.
Associated topics: intern, lab, laboratory, lab tech, lab technologist, qa, qc, quality, quality control, research associate

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