Associate Director* from AIC

Innova Solutions is immediately hiring for a Associate Director

Position type: Full time Contract.

Duration: 12 months

Location: Foster City, CA (Hybrid)

As a Associate Director, you will:

Job Description:

Hybrid with core on-site days Tuesday-Thursday

POSITION OVERVIEW:

You will act as the R&D Quality Business Partner to assigned groups, such as client R&D functions or vendors supporting client R&D.

You will provide strategic, expert advice and consultation on R&D quality, risk and continuous improvement with impact across cross-functional Good Clinical Practices (GCP).

You will educate assigned groups on client quality policy and procedural standards, GCP regulations and other requirements.

You will provide expert advice on GCP risk minimization and mitigation.

You will help the business understand potential impacts of risk and alternatives to best address risk.

You will also provide leadership support in escalating quality risks or issues. You will participate in Quality forums, cross-functional teams and/or projects.

You will act as the central point of contact for QMS-related communications to assigned groups; consolidating and channeling just-in-time information and resources to assist assigned groups.

You will collaborate with other R&D Quality groups to ensure just-in-time support and resources to assigned groups, including - data, reporting, training, audit, inspection, risk assessment and deviation/ CAPA management support. You may support client during regulatory inspections.

RESPONSIBILITIES:

• Serves as Quality Business Partner lead for assigned client R&D functions, programs and/or vendors. Handles multiple projects simultaneously and ensures overall and timely completion of tasks.
• Works closely with business to provide expert quality information, manage identified issues, and support continuous improvement.
• Acts as Subject Matter Expert supporting GCP cross portfolio risk assessment for all activities performed by assigned functions, vendors or relevant to assigned R&D programs.
• Collaborates with the Audit, Inspection and CAPA Management Team within R&D Quality as required on internal quality audits, regulatory agency inspections, risk assessment, deviations and CAPA activities.
• Assists in readiness preparation, and/or directly supports regulatory agency inspection.
• Supports deviation identification, reporting, and CAPA development.
• Supports evaluation of new regulations and potential implications for client R&D and/or R&D vendors.
• Evaluates, writes and/or reviews standard operating procedures, and performs other activities in support of an integrated cross-functional QMS.
• Collaborates with other R&D Quality teams to ensure assigned functions, programs or vendors have timely and robust support for quality data/ analytics and reporting, quality documentation and training, quality technology and systems validation, and other related activities.
• May lead or support projects.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

REQUIREMENTS:

Education & Experience

• PharmD/PhD with 2+ years' experience.
• MA/MS/MBA with 8+ years' relevant experience.
• BA/BS with 10+ years' relevant experience.
• Significant experience advising business functions in the biopharma industry on GCP quality and compliance requirements, evolving regulations, risk minimization and mitigation, and continuous improvement.
• Previous GCP quality experience at a Sponsor or CRO; Previous experience as an auditor highly desired.
• Experience working across a broad spectrum of quality and/or compliance activities, including authoring and reviewing SOPs, conducting internal auditing, supporting regulatory inspections, developing and managing CAPAs and deviations, and training others on quality and/or compliance requirements.
• Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials, or other drug development activities.
• Experience working with total quality management methodologies, such as Lean Six Sigma, is a plus.

Knowledge & Other Requirements :

• Thorough knowledge of standards, systems, policies and procedures that enable Good Clinical Practices (GCP), QMS operations and compliance within the biopharma industry. Experience with Good Clinical Laboratory Practices (GCLP), Good Pharmacovigilance (GVP) and Electronic Systems Compliance (ESC) is a plus.
• Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
• Demonstrates advanced business knowledge and analytical skills, as evidenced by strengths in assessing complex systems and data and understanding the quality and compliance implications.
• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
• Strong interpersonal skills and understanding of team dynamics.
• Strong communication and organizational skills.
• Strong negotiation and conflict resolution skills.

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.

Thank you!

Namrata Gautam

Senior Associate Recruitment

PHONE: (+1) 314-523-1818

EMAIL:

PAY RANGE AND BENEFITS:

Pay Range*: $100- $105 per hour.

*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centres across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

• One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
• ClearlyRated® Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.