Associate Director of Quality Assurance

1 month ago

Sellersville, United States Piramal Pharma Solutions Full time

The primary objective of the role is to provide Quality Operations support for both Clinical and Commercial Operations.Support includes data auditing for Quality Control operations such as raw material, finished good, stability and laboratory equipment qualification. QA IT support for the site to assure all production, laboratory equipment and software implementation meeting computer software regulatory requirements (21 CFR Part 11, Annex 11, GAMP 5). This role will be critical point of contact with respect to clients to provide leadership and key updates for all Quality Operational activities.


KEY ROLES/RESPONSIBILTIES:

  • Direct oversight of the following functions:
  • Personal Development, Commercial Operations, Clinical Operations, Data Auditing, and QA IT
  • Direct oversight of Quality Assurance, ensures the activities are performed and closed in a timely manner, specifically:


Deviations

CAPA

Change Control


  • Review and approve controlled documents requiring QA approval signature, including:


Executed cGMP Batch Records

Master Batch Production Records

Standard Operating Procedures

Product, Process, Test Method, and Equipment Qualification Protocols


  • Participate in client project meetings as well as PPS project meeting
  • Development and issuance of operational metrics related to record execution
  • Serve as the Subject Matter Expert (SME) on Quality Operational support activities
  • Accountable for the effective execution of processes carried out under departmental leaders (Pest Control, GMP Work Orders, Batch Disposition and Operational Quality Walk Through)
  • Establish and track the relevant KPIs
  • Periodic “stand-in” stand-in for Head of Quality duties, as designated
  • Periodic daily and monthly staffing schedules, capacity planning and cross-training efforts
  • QA management with identifying staffing needs and contributes to hiring decisions
  • Scheduling of data auditing to align with client objectives
  • Provide direction of CSV support needed for the site to ensure business continuity and support new equipment induction activities as well as an updates to software/hardware that are critical to the business
  • Supplier Management Program
  • Annual Product Review
  • ManageDepartmental Budget
  • Support, serve as Subject Matter Expert for: internal, customer and regulatory audits/inspections
  • Execute system/process gap analysis and implement CAPAs for identified gaps



KEY STAKEHOLDERS: EXTERNAL

1.) Clients – Commercial and Clinical

2.) Various Regulators including FDA, EU and PMDA


QUALIFICATION

B.A. or B.S in Biology, Life Science, Chemistry, or related scientific discipline


EXPERIENCE:

Minimum of ten (10) years in Quality (QA, QC, QS and/or Compliance) with progressive experience in a regulated cGMP industry is required, with three (3) years’ management experience. Must have experience working within a GMP oral solid dosage manufacturing environment. Contract development manufacturing experience is preferred.

  • Associate Director of Quality Assurance

    1 month ago

    Sellersville, United States Piramal Pharma Solutions Full time

    The primary objective of the role is to provide Quality Operations support for both Clinical and Commercial Operations.Support includes data auditing for Quality Control operations such as raw material, finished good, stability and laboratory equipment qualification. QA IT support for the site to assure all production, laboratory equipment and software...

  • Associate Director of Quality Assurance

    3 weeks ago

    Sellersville, United States Piramal Pharma Solutions Full time

    The primary objective of the role is to provide Quality Operations support for both Clinical and Commercial Operations.Support includes data auditing for Quality Control operations such as raw material, finished good, stability and laboratory equipment qualification. QA IT support for the site to assure all production, laboratory equipment and software...

  • Director of Quality

    1 month ago

    Sellersville, United States Piramal Pharma Solutions Full time

    The Director, Quality & Regulatory Affairs will maintain Sellersville Quality procedures and systems to ensure regulatory compliance. The incumbent will be an integral member of the Senior Leadership Team. The Director of Quality Operations is responsible for the quality unit at the site and for oversight of all quality related activities at the site.The...

  • Director of Quality

    2 months ago

    Sellersville, United States Piramal Pharma Solutions Full time

    The Director, Quality & Regulatory Affairs will maintain Sellersville Quality procedures and systems to ensure regulatory compliance. The incumbent will be an integral member of the Senior Leadership Team. The Director of Quality Operations is responsible for the quality unit at the site and for oversight of all quality related activities at the site.The...

  • Director of Quality

    2 months ago

    Sellersville, United States Piramal Pharma Solutions Full time

    The Director, Quality & Regulatory Affairs will maintain Sellersville Quality procedures and systems to ensure regulatory compliance. The incumbent will be an integral member of the Senior Leadership Team. The Director of Quality Operations is responsible for the quality unit at the site and for oversight of all quality related activities at the site.The...

  • Director of Quality

    2 days ago

    Sellersville, United States Piramal Pharma Solutions Full time

    The Director, Quality & Regulatory Affairs will maintain Sellersville Quality procedures and systems to ensure regulatory compliance. The incumbent will be an integral member of the Senior Leadership Team. The Director of Quality Operations is responsible for the quality unit at the site and for oversight of all quality related activities at the site.The...

  • Director of Quality

    2 months ago

    Sellersville, United States Piramal Pharma Solutions Full time

    The Director, Quality & Regulatory Affairs will maintain Sellersville Quality procedures and systems to ensure regulatory compliance. The incumbent will be an integral member of the Senior Leadership Team. The Director of Quality Operations is responsible for the quality unit at the site and for oversight of all quality related activities at the site.The...

  • Director of Quality

    3 weeks ago

    Sellersville, United States Piramal Pharma Solutions Full time

    The Director, Quality & Regulatory Affairs will maintain Sellersville Quality procedures and systems to ensure regulatory compliance. The incumbent will be an integral member of the Senior Leadership Team. The Director of Quality Operations is responsible for the quality unit at the site and for oversight of all quality related activities at the site.The...

  • Director of Quality

    3 weeks ago

    Sellersville, United States Piramal Pharma Solutions Full time

    The Director, Quality & Regulatory Affairs will maintain Sellersville Quality procedures and systems to ensure regulatory compliance. The incumbent will be an integral member of the Senior Leadership Team. The Director of Quality Operations is responsible for the quality unit at the site and for oversight of all quality related activities at the site.The...

  • Director of Nursing

    2 days ago

    Sellersville, United States Grace Inspired Living Full time

    **_Are you ready to pursue a rewarding career that inspires others and makes a positive difference? _**We are looking for a seasoned RN to Come and Join our team as a Director of Nursing at our Community at Rockhill! - We are located in Sellersville, PA at 3250 State Road_ **About Us**: Guided by God’s love, Grace Inspired Living is dedicated to providing...

  • Director of Nursing

    3 weeks ago

    Sellersville, United States Grace Inspired Living Full time

    Are you ready to pursue a rewarding career that inspires others and makes a positive difference? We are looking for a seasoned RN to Come and Join our team as a Director of Nursing at our Community at Rockhill!We are located in Sellersville, PA at 3250 State RoadAbout Us:Founded in 1935, the Community at Rockhill ( is a residential community for adults 65...

  • Director of Nursing

    3 weeks ago

    Sellersville, United States Grace Inspired Living Full time

    Are you ready to pursue a rewarding career that inspires others and makes a positive difference? We are looking for a seasoned RN to Come and Join our team as a Director of Nursing at our Community at Rockhill!We are located in Sellersville, PA at 3250 State RoadAbout Us:Founded in 1935, the Community at Rockhill (www.communityatrockhill.org) is a...

  • Director of Nursing

    2 weeks ago

    Sellersville, United States Grace Inspired Living Full time

    Are you ready to pursue a rewarding career that inspires others and makes a positive difference? We are looking for a seasoned RN to Come and Join our team as a Director of Nursing at our Community at Rockhill!We are located in Sellersville, PA at 3250 State RoadAbout Us:Founded in 1935, the Community at Rockhill ( is a residential community for adults 65...

  • Director of Nursing

    3 weeks ago

    Sellersville, PA, United States Grace Inspired Living Full time

    Are you ready to pursue a rewarding career that inspires others and makes a positive difference? We are looking for a seasoned RN to Come and Join our team as a Director of Nursing at our Community at Rockhill!We are located in Sellersville, PA at 3250 State RoadAbout Us:Founded in 1935, the Community at Rockhill (www.communityatrockhill.org) is a...

  • Associate Veterinarian- Sellersville, Pennsylvania

    3 weeks ago

    Sellersville, United States Rockhill Veterinary Associates Full time

    Job DescriptionJob DescriptionWe are proud to have over 63 years of veterinary experience in the community of Sellersville, PA, and the surrounding areas. Our seasoned team has over 120 years of combined experience with an emphasis on high-quality medicine and surgery as well as intensive care, overnight nursing care, and in-hospital specialists in Surgery,...

  • Associate Veterinarian- Sellersville, Pennsylvania

    2 months ago

    Sellersville, United States Rockhill Veterinary Associates Full time

    Job DescriptionJob DescriptionWe are proud to have over 63 years of veterinary experience in the community of Sellersville, PA, and the surrounding areas. Our seasoned team has over 120 years of combined experience with an emphasis on high-quality medicine and surgery as well as intensive care, overnight nursing care, and in-hospital specialists in Surgery,...

  • Mammography Technologist Training Program

    4 weeks ago

    Sellersville, United States Grand View Hospital Full time

    Responsibilities Grand View Health is seeking an energetic, patient focused Mammography Technologist to join our Mammography Training Program. Are you passionate about patient care and want to join a team recognized for excellence and chosen for caring? We offer state-of-the-art equipment in our Hospital Health Pavilion. Grow your career with us and apply...

  • Mammography Technologist Training Program

    3 weeks ago

    Sellersville, United States Grand View Hospital Full time

    Responsibilities Grand View Health is seeking an energetic, patient focused Mammography Technologist to join our Mammography Training Program. Are you passionate about patient care and want to join a team recognized for excellence and chosen for caring? We offer state-of-the-art equipment in our Hospital Health Pavilion. Grow your career with us and apply...

  • Client Services Associate

    3 weeks ago

    Sellersville, United States BAYADA Home Health Care Full time

    BAYADA Home Health Care has an immediate opening for an **Associate** in our **Sellersville, PA Pediatrics Office!** Are you looking for an exciting opportunity in a fast-growing industry? Do you want to make a difference in peoples lives while you grow your career and learn the business? Were BAYADA Home Health Care and we believe that our clients and their...

  • Client Services Associate

    4 weeks ago

    Sellersville, United States Bayada Full time

    Description BAYADA Home Health Care has an immediate opening for an Associatein our Sellersville, PA Pediatrics Office! Are you looking for an exciting opportunity in a fast-growing industry? Do you want to make a difference in people's lives while you grow your career and learn the business? We're BAYADA Home Health Care and we believe that our clients and...