30 days old

Manager R&D Quality & Risk Management

ACADIA Pharmaceuticals
Princeton, NJ 08540
  • Job Code
    117468201
ACADIA Pharmaceuticals

ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

Position Summary:

Responsible for managing assigned Research and Development (R&D) Quality and Risk Management activities at ACADIA, including assessment and quality control of ACADIA clinical trials' execution in a Good Clinical Practices (GCP) regulated environment. Additional areas of support include Drug Safety and Pharmacovigilance, Computer System Validation and Good Laboratory Practices (GLP). Candidate will be required to work closely with internal R&D teams and Contract Service Providers (CSPs) as clinical trials are designed and conducted. Will be required to identify emerging issues and, compliance risks, measure performance metrics, and suggest opportunities for improvement for clinical trial related processes and procedures and contribute to their implementation.

Primary Responsibilities:

  • Contribute to effective quality control and risk management of ACADIA R&D procedures and processes.
  • Ensure the continuous improvement of clinical trial processes and associated SOPs within Clinical Operations, trial monitoring, Data Management and Pharmacovigilance (PV).
  • Calculate, track and report appropriate process and/or compliance indicators (semi-automated metrics and manual spot-checks) in order to reinforce adherence to processes and procedures and to identify areas for improvement.
  • Work in close collaboration with colleagues in R&D Quality Management, ACADIA operational units such as Clinical Development, Clinical Operations, Data Management, and vendors (CSPs) in Drug Development.
  • Provide quality input and generate trial risk assessments to support clinical development teams, CROs, contractors and consultants.

Education/Experience/Skills:

  • Bachelors or Master's degree in life sciences, neuroscience, psychology, biochemistry, clinical pharmacology or related. An equivalent combination of relevant education and applicable job experience may be considered.
  • Minimum 5 years pharmaceutical/Health Care experience in a R&D regulated environment including some experience in R&D Quality Risk Management or R&D Quality Assurance systems and Health Authority regulations.
  • Experience in a matrix team environment and involvement and contribution to continuous improvement projects.

Must possess:

  • Experience with drug development process, including affinity with clinical protocol development, global trial management, site management & monitoring, drug safety, biostatistics & programming and/or data management.
  • Knowledge of GCP, including affinity with quality management and performance metrics and experience with Root Cause Analysis and CAPA development.
  • Experience with multiple IT programs and systems, including but not limited to Clinical Trial Management systems, eTMF, eCRFs, Microsoft Office (including above average Excel skills), quality workflow systems.
  • Knowledge of Good Laboratory Practices, PV, FDA and/or EMA regulations.
  • Excellent communication skills, both verbal and written. Able to work independently as well as in cross-functional teams.
  • Excellent pro-active, interpersonal, problem-solving, conflict resolving skills.
  • Flexibility to switch between projects and assignments; ability to manage multiple projects, work streams and activities on a daily basis.
  • Ability to establish and maintain frequent internal and external relationships with Development, Regulatory Affairs, Pharmacovigilance & Legal departments, regulatory agencies, CROs, clinical investigators, etc.
  • Ability to interpret and apply practical knowledge of regulations and guidelines for the immediate resolution of compliance issues and the pro-active management of GCP and PV quality risks under supervision if needed.
  • Ability to assess regulatory/compliance risk, identify areas of improvement and propose practical solutions.
  • Skilled at working effectively with business partners and management, and appropriately signal and escalate matters of significance to the organization.
  • Ability to travel up to 25% of the time.

Desired:

  • Experience with clinical development and subsequent commercialization of at least one product (small molecule preferred).
  • Experience with organizational change management, especially as it relates to embracing and promoting a culture of quality.
  • Experience with multi-sized organizations from start-up to large employers.
  • Experience with QA audits and Health Authority Inspections by FDA, EMA, MHRA, and PMDA.
  • Experience with Computer System Life Cycle management and principles.
  • Familiarity with Central Nervous System (CNS) therapeutic area is a big plus.

Scope:

May provide guidance to subordinates and/or manage department section, to achieve goals in accordance with established policies and to meet schedules and/or resolve problems. Receives assignments in the form of objectives. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. Works on issues of diverse scope which require evaluation of a variety of factors ad an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues.


PI117468201

<b>ACADIA Pharmaceuticals</b><br/><br/>ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity</em><br/><br/><p><strong><u>Position Summary:</u></strong></p> <p>Responsible for managing assigned Research and Development (R&D) Quality and Risk Management activities at ACADIA, including assessment and quality control of ACADIA clinical trials' execution in a Good Clinical Practices (GCP) regulated environment. Additional areas of support include Drug Safety and Pharmacovigilance, Computer System Validation and Good Laboratory Practices (GLP). Candidate will be required to work closely with internal R&D teams and Contract Service Providers (CSPs) as clinical trials are designed and conducted. Will be required to identify emerging issues and, compliance risks, measure performance metrics, and suggest opportunities for improvement for clinical trial related processes and procedures and contribute to their implementation.</p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Contribute to effective quality control and risk management of ACADIA R&D procedures and processes.</li> <li>Ensure the continuous improvement of clinical trial processes and associated SOPs within Clinical Operations, trial monitoring, Data Management and Pharmacovigilance (PV).</li> <li>Calculate, track and report appropriate process and/or compliance indicators (semi-automated metrics and manual spot-checks) in order to reinforce adherence to processes and procedures and to identify areas for improvement.</li> <li>Work in close collaboration with colleagues in R&D Quality Management, ACADIA operational units such as Clinical Development, Clinical Operations, Data Management, and vendors (CSPs) in Drug Development.</li> <li>Provide quality input and generate trial risk assessments to support clinical development teams, CROs, contractors and consultants.</li> </ul> <p><strong><u>Education/Experience/Skills:</u></strong></p> <ul> <li>Bachelors or Master's degree in life sciences, neuroscience, psychology, biochemistry, clinical pharmacology or related. An equivalent combination of relevant education and applicable job experience may be considered.</li> <li>Minimum 5 years pharmaceutical/Health Care experience in a R&D regulated environment including some experience in R&D Quality Risk Management or R&D Quality Assurance systems and Health Authority regulations.</li> <li>Experience in a matrix team environment and involvement and contribution to continuous improvement projects. </li> </ul> <p><u>Must possess:</u></p> <ul> <li>Experience with drug development process, including affinity with clinical protocol development, global trial management, site management & monitoring, drug safety, biostatistics & programming and/or data management. </li> <li>Knowledge of GCP, including affinity with quality management and performance metrics and experience with Root Cause Analysis and CAPA development. </li> <li>Experience with multiple IT programs and systems, including but not limited to Clinical Trial Management systems, eTMF, eCRFs, Microsoft Office (including above average Excel skills), quality workflow systems.</li> <li>Knowledge of Good Laboratory Practices, PV, FDA and/or EMA regulations.</li> <li>Excellent communication skills, both verbal and written. Able to work independently as well as in cross-functional teams.</li> <li>Excellent pro-active, interpersonal, problem-solving, conflict resolving skills.</li> <li>Flexibility to switch between projects and assignments; ability to manage multiple projects, work streams and activities on a daily basis.</li> <li>Ability to establish and maintain frequent internal and external relationships with Development, Regulatory Affairs, Pharmacovigilance & Legal departments, regulatory agencies, CROs, clinical investigators, etc.</li> <li>Ability to interpret and apply practical knowledge of regulations and guidelines for the immediate resolution of compliance issues and the pro-active management of GCP and PV quality risks under supervision if needed.</li> <li>Ability to assess regulatory/compliance risk, identify areas of improvement and propose practical solutions.</li> <li>Skilled at working effectively with business partners and management, and appropriately signal and escalate matters of significance to the organization.</li> <li>Ability to travel up to 25% of the time.</li> </ul> <p><u>Desired:</u></p> <ul> <li>Experience with clinical development and subsequent commercialization of at least one product (small molecule preferred).</li> <li>Experience with organizational change management, especially as it relates to embracing and promoting a culture of quality.</li> <li>Experience with multi-sized organizations from start-up to large employers.</li> <li>Experience with QA audits and Health Authority Inspections by FDA, EMA, MHRA, and PMDA.</li> <li>Experience with Computer System Life Cycle management and principles.</li> <li>Familiarity with Central Nervous System (CNS) therapeutic area is a big plus.</li> </ul> <p><strong><u>Scope:</u></strong></p> <p>May provide guidance to subordinates and/or manage department section, to achieve goals in accordance with established policies and to meet schedules and/or resolve problems. Receives assignments in the form of objectives. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. Works on issues of diverse scope which require evaluation of a variety of factors ad an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.</p> <p><strong><u>Physical Requirements:</u></strong></p> <p>While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues. </p> <p><em><span style="font-weight: 400;"><br/></span></em></p> <img src="https://analytics.click2apply.net/v/LYgRkOI1bp1dsB74iqMNX"> <p>PI117468201</p>

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Posted: 2020-01-25 Expires: 2020-02-25

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Manager R&D Quality & Risk Management

ACADIA Pharmaceuticals
Princeton, NJ 08540

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