Job description

Director of Compliance Job Description

SUMMARY

Responsibilities include providing direction for compliance activities to support current Good Manufacturing Practices (cGMPs). Participate in regulatory agency inspections and inspection agency correspondence. Responsible for supplier audit and internal audit programs. Control drug and list one chemical activities including DEA reporting activities. Responsible for federal, state, and international agency registrations, licenses, compliance filings (including drug listings) and customer/agency document request. Assist our international colleagues with similar activities as required. Responsible for ongoing contact with customer QA representatives regarding quality/technical agreements, audits, audit follow-up and general problem solving. Provide guidance and information to the company on new/proposed regulations and strategies for compliance. Ongoing contact with internal operations, sales, engineering, and quality department employees concerning compliance with customer requirements as well as cGMPs.

Scope of the position includes all Sharp Packaging US commercial Service locations (Allentown, Conshohocken, Macungie, and others that may be added to the portfolio or as directed). The impact of decisions relating to customer interface, regulatory inspections, development of documents, review of quality/ technical agreements, implementation planning for new products could expose the company to significant risk or economic loss.

ESSENTIAL DUTIES AND RESPONSIBILITIES: The all-inclusive list of responsibilities may be distributed to multiple supervisors/managers. Other duties may also be assigned.

Responsible for Compliance area during audit activities (regulatory, customer, supplier and internal).

• Participate in regulatory inspections and follow-up. Engage appropriate Quality and Operations employees as required.
• Oversight of surveillance audit programs (internal, customer, Agency) at all Sharp facilities that includes establishing an annual audit plan, conducting the audits and monitoring progress of follow-up actions. Engage appropriate Site Quality employees and Operations employees as required.
• Oversight of the supplier audit program that includes qualifying new suppliers, audit schedules and maintenance of approved supplier list. Ensure compliance with approved supplier and oversee certified supplier program.

Responsible for Controlled Substance Activities including (but not limited to) oversight of the following:

• Day-to-day activities of the DEA Compliance program as it relates to Title 21 CFR, Part 1300, and the Drug Enforcement Administration (DEA), as well as ensure compliance with all federal and state regulations. Coordination and support of all DEA regulated activities for all operations: tracking, recording, monitoring and regulatory reporting of all movements of controlled substances from receiving, manufacturing, packaging, distribution.
• Preparation and submission of periodic reports for the DEA (ARCOS, YERS, etc.). Ensuring that proper licenses and registrations necessary to receive, manufacture, package, ship product, importer, and exporter.
• Coordinate all year-end physical inventory activities for the submission of DEA Licenses including discrepancy investigations, balancing inventories for transfers, shipments, receipts and destructions to reconcile the drug within the allowable accountability percentage.

Customer Support Activities:

• Annual product reviews, standard operating procedures related to functional activities specifications and change control.
• Assisting with the review of Quality/Technical agreements with customers.
• Licensing and site registrations including assistance with our foreign sites.
• Customer regulatory requests including review of filing information, application assistance etc.
• Establishment and maintenance of Drug Listing requirements if/as required.
• Coordinating appropriate problem-solving initiatives to address customer or regulatory quality issues.
• Establishing new procedures as required based on customer needs.

General Compliance Status

• Identification of new compliance trends, agency changes and strategies to keep the company in good standing.

SUPERVISORY RESPONSIBILITIES:

• Direct supervision of compliance, audit groups and DEA activities for the company. Hires and develops a high-performing quality team to ensure robust quality systems are implemented and sustained including:
• SOP/Document Management: Manage approval of all instruction sets, specifications, sampling instructions, test methods and other Quality control procedures directly related to operations and other cGMP activities.
• Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause.
• Training: Ensure all departmental personnel, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations.
• Oversight for inspection preparation, management, and response process.
• Provide quality input across the manufacturing network as required.
• Other related duties as assigned.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE:

• B.S. degree preferably in science related field.
• 10 years of experience in biopharmaceutical based Good Manufacturing Practice manufacturing/packaging activities or related.
• 5 years of direct supervisory experience of technical professionals with demonstrated effectiveness to recruit and train a team as well as provide continued guidance, mentorship, and support to staff.
• Comprehensive knowledge of FDA and DEA regulations and experience in US and international regulatory agency inspections.
• Strong knowledge and application of the CFRs and cGMPs and involvement in multiple regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international) and experience reviewing and/or authoring regulatory filings a plus.
• Experience leading both internal and external supplier audits, identifying findings, driving resolution, and providing closure report.
• Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
• Demonstrated ability to perform long-term project planning, team building, budgeting, and operational excellence.

LANGUAGE SKILLS:

• Excellent oral and written communication skills with strong technical writing experience.
• Ability to read and interpret common scientific data. Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community and colleagues.

REASONING ABILITY:

Ongoing contact with internal Operations, Sales, Engineering, and Quality Department employees, plus customer QA representatives. Contact with regulatory personnel concerning compliance with customer requirements as well as cGMP’s. Customers agreements and regulatory guidelines are available to assist, however frequent review and reasonable interpretation are necessary to keep current. Good mental skills for analysis and problem solving are needed. Need an ability to negotiate to reach a common solution meeting everyone’s needs.

CERTIFICATES, LICENSES, REGISTRATIONS:

Must be proficient in Microsoft Office Suite.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions.

Travel to customers on an as needed basis.

Job Type: Full-time

Pay: From $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Allentown, PA 18106: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Compliance management: 1 year (Preferred)

Work Location: In person

seankuhnke.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, seankuhnke.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, seankuhnke.com is the ideal place to find your next job.